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Kang, Hae-Ji, Ki-Back Chu, Keon-Woong Yoon, Gi-Deok Eom, Jie Mao, and Fu-Shi Quan. "Cross-Protection Induced by Virus-like Particles Derived from the Influenza B Virus." Biomedicines 10, no. 7 (July 6, 2022): 1618. http://dx.doi.org/10.3390/biomedicines10071618.
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The mismatch between the circulating influenza B virus (IBV) and the vaccine strain contributes to the rapid emergence of IBV infection cases throughout the globe, which necessitates the development of effective vaccines conferring broad protection. Here, we generated influenza B virus-like particle (VLP) vaccines expressing hemagglutinin, neuraminidase, or both antigens derived from the influenza B virus (B/Washington/02/2019 (B/Victoria lineage)-like virus, B/Phuket/3073/2013 (B/Yamagata lineage)-like virus. We found that irrespective of the derived antigen lineage, immunizing mice with the IBV VLPs significantly reduced lung viral loads, minimized bodyweight loss, and ensured 100% survival upon Victoria lineage virus B/Colorado/06/2017 challenge infection. These results were closely correlated with the vaccine-induced antibody responses and HI titer in sera, IgG, IgA antibody responses, CD4+ and CD8+ T cell responses, germinal center B cell responses, and inflammatory cytokine responses in the lungs. We conclude that hemagglutinin, neuraminidase, or both antigen-expressing VLPs derived from these influenza B viruses that were circulating during the 2020/21 season provide cross-protections against mismatched Victoria lineage virus (B/Colorado/06/2017) challenge infections.
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Ping, Jihui, Tiago J. S. Lopes, Gabriele Neumann, and Yoshihiro Kawaoka. "Development of high-yield influenza B virus vaccine viruses." Proceedings of the National Academy of Sciences 113, no. 51 (December 5, 2016): E8296—E8305. http://dx.doi.org/10.1073/pnas.1616530113.
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The burden of human infections with influenza A and B viruses is substantial, and the impact of influenza B virus infections can exceed that of influenza A virus infections in some seasons. Over the past few decades, viruses of two influenza B virus lineages (Victoria and Yamagata) have circulated in humans, and both lineages are now represented in influenza vaccines, as recommended by the World Health Organization. Influenza B virus vaccines for humans have been available for more than half a century, yet no systematic efforts have been undertaken to develop high-yield candidates. Therefore, we screened virus libraries possessing random mutations in the six “internal” influenza B viral RNA segments [i.e., those not encoding the major viral antigens, hemagglutinin (HA) and neuraminidase NA)] for mutants that confer efficient replication. Candidate viruses that supported high yield in cell culture were tested with the HA and NA genes of eight different viruses of the Victoria and Yamagata lineages. We identified combinations of mutations that increased the titers of candidate vaccine viruses in mammalian cells used for human influenza vaccine virus propagation and in embryonated chicken eggs, the most common propagation system for influenza viruses. These influenza B virus vaccine backbones can be used for improved vaccine virus production.
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Kovtun, O. P., V. V. Romanenko, I. V. Feldblum, A. U. Sabitov, and A. V. Ankudinova. "The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old." BIO Web of Conferences 22 (2020): 02001. http://dx.doi.org/10.1051/bioconf/20202202001.
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Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one.
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Virk, Ramandeep K., Jayanthi Jayakumar, Ian H. Mendenhall, Mahesh Moorthy, Pauline Lam, Martin Linster, Julia Lim, et al. "Divergent evolutionary trajectories of influenza B viruses underlie their contemporaneous epidemic activity." Proceedings of the National Academy of Sciences 117, no. 1 (December 16, 2019): 619–28. http://dx.doi.org/10.1073/pnas.1916585116.
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Influenza B viruses have circulated in humans for over 80 y, causing a significant disease burden. Two antigenically distinct lineages (“B/Victoria/2/87-like” and “B/Yamagata/16/88-like,” termed Victoria and Yamagata) emerged in the 1970s and have cocirculated since 2001. Since 2015 both lineages have shown unusually high levels of epidemic activity, the reasons for which are unclear. By analyzing over 12,000 influenza B virus genomes, we describe the processes enabling the long-term success and recent resurgence of epidemics due to influenza B virus. We show that following prolonged diversification, both lineages underwent selective sweeps across the genome and have subsequently taken alternate evolutionary trajectories to exhibit epidemic dominance, with no reassortment between lineages. Hemagglutinin deletion variants emerged concomitantly in multiple Victoria virus clades and persisted through epistatic mutations and interclade reassortment—a phenomenon previously only observed in the 1970s when Victoria and Yamagata lineages emerged. For Yamagata viruses, antigenic drift of neuraminidase was a major driver of epidemic activity, indicating that neuraminidase-based vaccines and cross-reactivity assays should be employed to monitor and develop robust protection against influenza B morbidity and mortality. Overall, we show that long-term diversification and infrequent selective sweeps, coupled with the reemergence of hemagglutinin deletion variants and antigenic drift of neuraminidase, are factors that contributed to successful circulation of diverse influenza B clades. Further divergence of hemagglutinin variants with poor cross-reactivity could potentially lead to circulation of 3 or more distinct influenza B viruses, further complicating influenza vaccine formulation and highlighting the urgent need for universal influenza vaccines.
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da Costa, Kelly A. S., Joanne Marie M. Del Rosario, Matteo Ferrari, Sneha Vishwanath, Benedikt Asbach, Rebecca Kinsley, Ralf Wagner, Jonathan L. Heeney, George W. Carnell, and Nigel J. Temperton. "Influenza A (N1-N9) and Influenza B (B/Victoria and B/Yamagata) Neuraminidase Pseudotypes as Tools for Pandemic Preparedness and Improved Influenza Vaccine Design." Vaccines 10, no. 9 (September 14, 2022): 1520. http://dx.doi.org/10.3390/vaccines10091520.
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To better understand how inhibition of the influenza neuraminidase (NA) protein contributes to protection against influenza, we produced lentiviral vectors pseudotyped with an avian H11 hemagglutinin (HA) and the NA of all influenza A (N1–N9) subtypes and influenza B (B/Victoria and B/Yamagata). These NA viral pseudotypes (PV) possess stable NA activity and can be utilized as target antigens in in vitro assays to assess vaccine immunogenicity. Employing these NA PV, we developed an enzyme-linked lectin assay (pELLA) for routine serology to measure neuraminidase inhibition (NI) titers of reference antisera, monoclonal antibodies and post-vaccination sera with various influenza antigens. We also show that the pELLA is more sensitive than the commercially available NA-Fluor™ in detecting NA inhibition in these samples. Our studies may lead to establishing the protective NA titer that contributes to NA-based immunity. This will aid in the design of superior, longer lasting and more broadly protective vaccines that can be employed together with HA-targeted vaccines in a pre-pandemic approach.
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Campbell, Angela P., Constance E. Ogokeh, Geoffrey A. Weinberg, Julie A. Boom, Janet A. Englund, John V. Williams, Natasha B. Halasa, et al. "178. Vaccine Effectiveness Against Influenza-associated Hospitalizations and Emergency Department (ED) Visits Among Children in the United States in the 2019–2020 Season." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S217—S218. http://dx.doi.org/10.1093/ofid/ofaa439.488.
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Abstract Background The 2019–20 influenza season was predominated by early onset B/Victoria viruses followed by A(H1N1)pdm09 virus circulation. Over 95% of circulating B/Victoria viruses were subclade V1A.3, different from the Northern Hemisphere vaccine strain. Annual estimates of influenza vaccine effectiveness (VE) are important because of frequent changes in circulating and vaccine viruses. Methods We assessed VE among children 6 months–17 years old with acute respiratory illness and <10 days of symptoms enrolled during the 2019–20 influenza season at 7 pediatric hospitals (ED patients < 5 years at 3 sites) in the New Vaccine Surveillance Network. Combined mid-turbinate/throat swabs were tested for influenza virus using molecular assays. We estimated age-stratified VE from a test-negative design using logistic regression to compare odds of vaccination among children testing positive versus negative for influenza, adjusting for age in years, enrollment month, and site. For these preliminary analyses, vaccination status was by parental report. Results Among 2022 inpatients, 324 (16%) were influenza positive: 38% with influenza B/Victoria alone and 44% with influenza A(H1N1)pdm09 alone (Table). Among 2066 ED children, 653 (32%) were influenza positive: 45% with influenza B/Victoria alone and 43% with influenza A(H1N1)pdm09 alone. VE was 62% (95% confidence interval [CI], 51%–70%) against any influenza-related hospitalizations, 68% (95% CI, 55%–78%) for A(H1N1)pdm09 and 55% (95% CI, 35%–69%) for B/Victoria. VE by age group for any influenza-related hospitalizations was 57% (95% CI, 40%–69%) among children 6 months to < 5 years and 66% (95% CI, 49%–77%) among children 5–17 years. VE was 53% (95% CI, 42%–62%) against any influenza-related ED visits, 46% (95% CI, 28%–60%) for A(H1N1)pdm09 and 54% (95% CI, 39%–66%) for B/Victoria. VE by age group was 52% (95% CI, 37%–63%) among children 6 months to < 5 years and 42% (95% CI, 16%–60%) among children 5–17 years. Conclusion Influenza vaccination in the 2019–20 season provided substantial protection against laboratory-confirmed influenza-associated hospitalizations and ED visits associated with the two predominantly circulating influenza viruses among children, including against the emerging B/Victoria virus V1A.3 subclade. Disclosures Janet A. Englund, MD, AstraZeneca (Scientific Research Study Investigator)GSK group of companies (Scientific Research Study Investigator)Meissa vaccines (Consultant)Merck (Scientific Research Study Investigator)Sanofi Pasteur (Consultant) John V. Williams, MD, GlaxoSmithKline (Advisor or Review Panel member)IDConnect (Advisor or Review Panel member)Quidel (Advisor or Review Panel member) Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support) Christopher J. Harrison, MD, GSK (Grant/Research Support, Infant menigiciccal B conjugate vaccine trial)Merck (Research Grant or Support, Infant pneumococcal conjugate vaccine trial)
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Yakubu, Alhassan Mohammed, Nii Ayite Aryee, Evelyn Yayra Bonney, Erasmus Nikoi Kotey, Joseph Humphrey Kofi Bonney, Michael R. Wiley, Catherine B. Pratt, et al. "Molecular characterization of haemagglutinin genes of influenza B viruses circulating in Ghana during 2016 and 2017." PLOS ONE 17, no. 9 (September 23, 2022): e0271321. http://dx.doi.org/10.1371/journal.pone.0271321.
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Recent reports of haemagglutinin antigen (HA) mismatch between vaccine composition strains and circulating strains, have led to renewed interest in influenza B viruses. Additionally, there are concerns about resistance to neuraminidase inhibitors in new influenza B isolates. To assess the potential impact in Ghana, we characterized the lineages of influenza B viruses that circulated in Ghana between 2016 and 2017 from different regions of the country: Southern, Northern and Central Ghana. Eight representative specimens from the three regions that were positive for influenza B virus by real-time RT-PCR were sequenced and compared to reference genomes from each lineage. A total of eleven amino acids substitutions were detected in the B/Victoria lineage and six in the B/Yamagata lineage. The strains of influenza B viruses were closely related to influenza B/Brisbane/60/2008 and influenza B/Phuket/3073/2013 for the Victoria and Yamagata lineages, respectively. Three main amino acid substitutions (P31S, I117V and R151K) were found in B/Victoria lineages circulating between 2016 and 2017, while one strain of B/Victoria possessed a unique glycosylation site at amino acid position 51 in the HA2 subunit. Two main substitutions (L172Q and M251V) were detected in the HA gene of the B/Yamagata lineage. The U.S. CDC recently reported a deletion sub-group in influenza B virus, but this was not identified among the Ghanaian specimens. Close monitoring of the patterns of influenza B evolution is necessary for the efficient selection of representative viruses for the design and formulation of effective influenza vaccines.
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Portela Catani, João Paulo, Tine Ysenbaert, Anouk Smet, Marnik Vuylsteke, Thorsten U. Vogel, and Xavier Saelens. "Anti-neuraminidase and anti-hemagglutinin immune serum can confer inter-lineage cross protection against recent influenza B." PLOS ONE 18, no. 1 (January 23, 2023): e0280825. http://dx.doi.org/10.1371/journal.pone.0280825.
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Influenza B viruses (IBV) are responsible for a considerable part of the burden caused by influenza virus infections. Since their emergence in the 1980s, the Yamagata and Victoria antigenic lineages of influenza B circulate in alternate patterns across the globe. Furthermore, their evolutionary divergence and the appearance of new IBV subclades complicates the prediction of future influenza vaccines compositions. It has been proposed that the addition of the neuraminidase (NA) antigen could potentially induce a broader protection and compensate for hemagglutinin (HA) mismatches in the current vaccines. Here we show that anti-NA and -HA sera against both Victoria and Yamagata lineages have limited inter-lineage cross-reactivity. When transferred to mice prior to infection with a panel of IBVs, anti-NA sera were as potent as anti-HA sera in conferring protection against homologous challenge and, in some cases, conferred superior protection against challenge with heterologous IBV strains.
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Kishida, Noriko, Seiichiro Fujisaki, Masaru Yokoyama, Hironori Sato, Reiko Saito, Hideyuki Ikematsu, Hong Xu, et al. "Evaluation of Influenza Virus A/H3N2 and B Vaccines on the Basis of Cross-Reactivity of Postvaccination Human Serum Antibodies against Influenza Viruses A/H3N2 and B Isolated in MDCK Cells and Embryonated Hen Eggs." Clinical and Vaccine Immunology 19, no. 6 (April 4, 2012): 897–908. http://dx.doi.org/10.1128/cvi.05726-11.
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ABSTRACTThe vaccine strains against influenza virus A/H3N2 for the 2010-2011 season and influenza virus B for the 2009-2010 and 2010-2011 seasons in Japan are a high-growth reassortant A/Victoria/210/2009 (X-187) strain and an egg-adapted B/Brisbane/60/2008 (Victoria lineage) strain, respectively. Hemagglutination inhibition (HI) tests with postinfection ferret antisera indicated that the antisera raised against the X-187 and egg-adapted B/Brisbane/60/2008 vaccine production strains poorly inhibited recent epidemic isolates of MDCK-grown A/H3N2 and B/Victoria lineage viruses, respectively. The low reactivity of the ferret antisera may be attributable to changes in the hemagglutinin (HA) protein of production strains during egg adaptation. To evaluate the efficacy of A/H3N2 and B vaccines, the cross-reactivities of postvaccination human serum antibodies against A/H3N2 and B/Victoria lineage epidemic isolates were assessed by a comparison of the geometric mean titers (GMTs) of HI and neutralization (NT) tests. Serum antibodies elicited by the X-187 vaccine had low cross-reactivity to both MDCK- and egg-grown A/H3N2 isolates by HI test and narrow cross-reactivity by NT test in all age groups. On the other hand, the GMTs to B viruses detected by HI test were below the marginal level, so the cross-reactivity was assessed by NT test. The serum neutralizing antibodies elicited by the B/Brisbane/60/2008 vaccine reacted well with egg-grown B viruses but exhibited remarkably low reactivity to MDCK-grown B viruses. The results of these human serological studies suggest that the influenza A/H3N2 vaccine for the 2010-2011 season and B vaccine for the 2009-2010 and 2010-2011 seasons may possess insufficient efficacy and low efficacy, respectively.
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Kostinov, Mikhail P., Alexander P. Cherdantsev, Nelli K. Akhmatova, Daria A. Praulova, Aristitsa M. Kostinova, Elina A. Akhmatova, and Evgeniia O. Demina. "Immunogenicity and safety of subunit influenza vaccines in pregnant women." ERJ Open Research 4, no. 2 (April 2018): 00060–2017. http://dx.doi.org/10.1183/23120541.00060-2017.
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Pregnancy is a condition of modulated immune suppression, so this group of patients has increased risk of infectious diseases.Trivalent subunit vaccines, unadjusted Agrippal S1 (group I) and immunoadjuvant Grippol Plus (group II), containing 5 μg of actual influenza virus strains, were administered respectively to 37 and 42 women in the second and third trimester of physiological pregnancy.The administration of subunit influenza vaccines was accompanied by the development of local reactions in no more than 10% of patients, compared with 4.9% of the 41 pregnant women in the placebo group (group III). Systemic reactions were of a general somatic nature, did not differ between vaccinated and placebo groups, and were not associated with vaccination. Physiological births in groups I, II and III were 94.6%, 92.9% and 85.4%, respectively, and the birth rates of children without pathologies were 91.9%, 90.5% and 80.5%, respectively, and were comparable between groups. Vaccination stimulated the production of protective antibodies against influenza virus strains in 64.8–94.5% of patients after immunisation with an unadjusted vaccine and in 72.5–90.0% of patients after the administration of an immunoadjuvant vaccine. After 9 months, antibody levels were recorded in 51.3–72.9% in group I and 54.2–74.2% in group II. Immunisation against influenza in pregnant women provided a high level of seroprotection and seroconversion. Nevertheless, the level of seroprotection against the influenza strain A(H3N2, Victoria) was slightly lower in the group immunised with an unadjusted vaccine compared to those vaccinated with the immunoadjuvant vaccine.
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Ignatova, Galina L., and Vladimir N. Antonov. "The actuality of preventing influenza and pneumococcal infection during the ongoing COVID-19 pandemic." Consilium Medicum 23, no. 3 (2021): 275–79. http://dx.doi.org/10.26442/20751753.2021.3.200765.
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The article discusses the issues of vaccine prevention of influenza and pneumococcal infections during the ongoing pandemic of the new coronavirus infection COVID-19. Statistical data on the prevalence of these infections at the current time are provided. Co-infection can increase the symptoms of the diseases in these cases, and managing this condition is important for certain groups of patients. Respiratory viruses induce the attachment of pneumococcus, Pseudomonas aeruginosa and Hemophilus bacillus to the epithelial cells of the respiratory tract. The WHO position on influenza vaccination in the context of the COVID-19 pandemic is presented, and its main provisions are analyzed. Recommendations on the use of the main types of vaccines are given. Currently, the priority is to use 4-valent vaccines that ensure the development of the most stable immunity. In the Russian Federation, such a vaccine that meets all WHO recommendations is Ultrix Quadri, a tetravalent inactivated split influenza vaccine. The drug is a mixture of protective surface and internal antigens of influenza viruses of type A [subtypes A(H1N1) and A(H3N2)] and type B (Yamagata line and Victoria line). The use of vaccination schemes for pneumococcal infection was also discussed.
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Nguyen, Van Hung, Yvonne Hilsky, and Joaquin Mould-Quevedo. "The Epidemiological and Economic Impact of a Cell-Based Quadrivalent Influenza Vaccine in Adults in the US: A Dynamic Modeling Approach." Vaccines 9, no. 10 (September 28, 2021): 1095. http://dx.doi.org/10.3390/vaccines9101095.
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Mutations of the H3N2 vaccine strain during the egg-based vaccine manufacturing process partly explain the suboptimal effectiveness of traditional seasonal influenza vaccines. Cell-based influenza vaccines improve antigenic match and vaccine effectiveness by avoiding such egg-adaptation. This study evaluated the public health and economic impact of a cell-based quadrivalent influenza vaccine (QIVc) in adults (18–64 years) compared to the standard egg-based quadrivalent influenza vaccine (QIVe) in the US. The impact of QIVc over QIVe in public health and cost outcomes was estimated using a dynamic age-structured SEIR transmission model, which accounted for four circulating influenza strains [A/H1N1pdm9, A/H3N2, B(Victoria), and B(Yamagata)] and was calibrated on the 2013–2018 influenza seasons. The robustness of the results was assessed in univariate and probabilistic sensitivity analyses. Switching from QIVe to QIVc in 18- to 64-year-olds may prevent 5.7 million symptomatic cases, 1.8 million outpatient visits, 50,000 hospitalizations, and 5453 deaths annually. The switch could save 128,000 Quality-Adjusted Life Years (QALYs) and US $ 845 M in direct costs, resulting in cost-savings in a three-year time horizon analysis. Probabilistic sensitivity analyses confirmed the robustness of the cost-saving result. The analysis shows that QIVc is expected to prevent hospitalizations and deaths, and result in substantial savings in healthcare costs.
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Sarker, Moumita, Angela Branche, Michael Peasley, and David Topham. "2737. Comparison of Antibody Responses to Vaccination with a Pure Hemagglutinin Influenza Vaccine (rHA) and Licensed Subvirion Influenza Vaccine Made in Eggs or Cell Culture in Adults 60 Years and Older." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S963. http://dx.doi.org/10.1093/ofid/ofz360.2415.
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Abstract Background Influenza is associated with increased mortality and morbidity for older adults. High-dose egg grown trivalent inactivated influenza vaccine (Fluzone HD) is safe and provides superior immune responses in older adults compared with standard dose (SD). Recently, two new vaccines have been licensed in the United States: cell cultured inactivated vaccine FluCelVax and baculovirus-expressed pure hemagglutinin (HA) vaccine FluBlok. Data from one study demonstrated higher efficacy with FluBlok than SD Fluzone in older adults. There is no data however comparing HD Fluzone to FluBlok and FluCelVax has not been studied at all. The purpose of this study was to assess hemagglutinin inhibition (HAI) antibody responses to vaccination with three vaccines in adults ≥ 60 years. Methods Adults ≥ 60 years were randomly assigned to receive one of the three vaccines: Fluzone HD, FluBlok and FluCelVax (Figure 1). Active influenza-like illness (ILI) surveillance was conducted with bi-weekly telephone calls. Serum samples were collected prior to vaccination and at day 7, 14, 28 and 180 and antibody responses assessed by HAI titer to A/Singapore/INFIMH-16–0019(H3N2), A/Michigan/45/2015(H1N1) and B/Colorado/6/2017 (Victoria) viruses as well as a circulating H3N2 strain. The primary endpoint was a 4-fold rise in antibody titer at day 28. Results 48 subjects were vaccinated in October 2018. Mean age was 69 and 65% were female. Two subjects reported ILI symptoms and one was positive for infection (H1N1). A majority of subjects demonstrated pre-existing antibody to all three viruses (Figure 2, Blue). Geometric mean titers (GMT) for antibody responses to the influenza A viruses were similar for FluBlok (FB) and HD Fluzone (FZ) but lower for FluCelVax(FCB) subjects (Figure 2, Orange). A higher percent of FlubBlok subjects demonstrated 4-fold rise in antibody responses to the Victoria influenza B virus (FB GMT 140 vs. FZ GMT 116, P = 0.26). Conclusion In this small study, antibody responses were similar or higher in older adults after vaccination with FluBlok compared with Fluzone HD with lower responses demonstrated with FluCelvax. Emerging concerns about HA egg adaptation during vaccine development compels further study to determine the appropriate vaccination strategy for this vulnerable population. Disclosures All authors: No reported disclosures.
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Postma, Maarten, Stephen I. Pelton, Victoria Divino, Joaquin F. Mould-Quevedo, Drishti Shah, Mitchell DeKoven, and Girishanthy Krishnarajah. "29. Impact of Enhanced Influenza Vaccines on Direct Healthcare Costs for the U.S. Elderly: A Comprehensive Real-World Evaluation of Adjuvanted Trivalent Influenza Vaccine Compared to Trivalent High-Dose Influenza Vaccine for the 2018–19 Influenza Season." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S38—S39. http://dx.doi.org/10.1093/ofid/ofaa439.074.
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Abstract Background Influenza generates a substantial economic burden ($3.2B in the U.S. annually) due to direct medical costs such as physician office visits or hospitalizations, especially among the elderly. Recent published literature for the 2018–19 influenza season has demonstrated similar clinical effectiveness between adjuvanted trivalent influenza vaccine (aTIV) and trivalent high dose influenza vaccine (TIV-HD). This research aimed to assess the annualized mean all-cause and influenza-related healthcare costs among subjects 65+ years vaccinated with aTIV or TIV-HD during the 2018–19 influenza season. Methods A retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index, comorbidities, indicators of frail health status, and pre-index hospitalization rates. Treatment selection bias was adjusted through 1:1 propensity score matching (PSM). Economic outcomes included annualized mean all-cause costs and influenza-related costs, which comprised influenza-related hospitalizations, emergency room (ER) visits, and physician office visits costs. Mean costs were compared using paired t-test. Adjusted analyses were conducted using generalized estimating equation (GEE) models, with two-part models for influenza-related costs. With the GEEs, adjustment for outliers (99th percentile) were addressed and predicted healthcare costs were obtained through bootstrapping (500 replications). Results During the 2018–19 influenza season, the PSM sample comprised 561,243 recipients of aTIV and 561,243 recipients of TIV-HD. Following GEE adjustment, predicted mean annualized all-cause and influenza-related costs per patient were statistically similar between aTIV and TIV-HD (US$9,676 vs. US$9,625 and US$23.75 vs. US$21.79, respectively). Both aTIV and TIV-HD were comparable in terms of predicted mean annualized costs for influenza-related hospitalizations (US$20.28 vs. US$18.13) and influenza-related office visits (US$1.29 vs. US$1.34). Conclusion In adjusted analyses, total all-cause and influenza-related healthcare costs were comparable among elderly subjects vaccinated with either aTIV or TIV-HD. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)
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Otani, Naruhito, Kazuhiko Nakajima, Kaori Ishikawa, Kaoru Ichiki, Yoshiko Yoda, Takashi Ueda, Yoshio Takesue, et al. "Comparison of the Hemagglutination Inhibition Titers against Influenza Vaccine Strains in Japan from the 2017/2018 to 2021/2022 Seasons Using a Single Set of Serum Samples." Viruses 14, no. 7 (June 30, 2022): 1455. http://dx.doi.org/10.3390/v14071455.
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In Japan, inactivated influenza vaccines are used. We measured titers of antibodies to vaccine strains of three influenza types—influenza A (H1N1), influenza A (H3N2), and influenza B/Victoria—from the 2017/2018 to 2021/2022 seasons, but not for influenza A (H3N2) from the 2018/2019 season, using a single set of serum samples from 34 healthy volunteers, and assessed the consistency in antibody positivity between seasons. The antibody titers in the 2017/2018 season were used as a reference. The influenza A (H1N1) antibody titer in 2019/2020 did not differ significantly from that in the 2017/2018 season, but the titers varied in the two subsequent seasons. The influenza A (H3N2) antibody titers toward the 2019/2020, 2020/2021, and 2021/2022 seasonal viruses differed significantly from that in the 2017/2018 season. The influenza B/Victoria antibody titer toward the 2019/2020 seasonal antigen differed from that in the 2017/2018 season, and the antibody positivity was inconsistent between seasons; however, the antibody titer in the 2020/2021 season did not differ significantly from those in the prior two seasons, and the antibody positivity was consistent between seasons. Antibody titers and their consistency can be used to evaluate cross-immunity of antibodies.
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Pelton, Stephen I., Maarten Postma, Victoria Divino, Drishti Shah, Joaquin F. Mould-Quevedo, Mitchell DeKoven, and Girishanthy Krishnarajah. "6. MF59 ASSURANCE 2: A Real-world Study to Estimate the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-based Trivalent High-dose Among U.S. Older Adults During 2018–19 Influenza Season." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S3. http://dx.doi.org/10.1093/ofid/ofaa417.005.
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Abstract Background In the 2018–19 influenza season, influenza resulted in almost 280,000 hospitalizations and over 25,000 deaths in U.S. adults > 65 years. This study aimed to evaluate the relative vaccine effectiveness (rVE) of adjuvant trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, office visits and hospitalization/ER visit for cardio-respiratory disease (CRD) among older adults for the 2018–19 flu season. Methods A retrospective cohort analysis of older adults (> 65 years) was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits and office visits and any hospitalization/ER visit for CRD (based on diagnoses codes). An unrelated outcome, urinary tract infection (UTI) hospitalization, was assessed. Results During 2018–19 flu season, following IPTW analyses, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (6.6%; 95% CI: 2.8%-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) for prevention of influenza-related hospitalizations/ER visits but more effective than TIV-HD (2.6%; 95% CI: 2.0%-3.2%) in reducing hospitalizations/ER visits for CRD. No treatment effect was identified for control condition (UTI hospitalization). Conclusion In adjusted analyses, aTIV reduced influenza-related office visits and CRD hospitalizations/ER visits compared to TIV-HD. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Maarten Postma, Dr., IQVIA (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)
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Krasilnikov, I. V., A. V. Ivanov, A. M. Nikolaeva, O. V. Belyakova, E. K. Shevchenko, N. A. Mikhailova, I. A. Leneva, and V. V. Zverev. "Preclinical study of immunogenicity of adjuvanted quadrivalent subunit influenza vaccine." Journal of microbiology, epidemiology and immunobiology 99, no. 3 (July 28, 2022): 300–308. http://dx.doi.org/10.36233/0372-9311-244.
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Background. Preventive vaccination is a vitally important strategic aspect of protection of the population against severe effects of influenza epidemics. The priority attention is given to development of effective tetravalent vaccines containing antigens of two influenza A lineages (H1N1, H3N2) and two influenza B lineages (Victoria and Yamagata) in combination with immunoadjuvants.The aim of the work was to conduct the preclinical study of the immunogenicity and protective efficacy of the innovative tetravalent subunit vaccine containing antigens of influenza A and B viruses as well as a corpuscular adjuvant.Materials and methods. The study was conducted using female BALB/c mice. The tetravalent vaccine and monovalent intermediate vaccines combined with a betulin adjuvant were injected intraperitoneally two times at a 14-day interval. The immunogenic activity was measured by the hemagglutination inhibition assay. The protective activity of the vaccine was assessed by changes in the viral load, body weight and survival rates using the mouse model of fatal influenza A H1N1 virus infection.Results. The mice vaccinated with the adjuvanted quadrivalent subunit influenza vaccine produced antibodies against all four influenza viruses included in the vaccine; the mean antibody titers in the hemagglutination inhibition assay were above 1 : 40. The second-dose vaccination induced a significant increase in levels of antibodies against all four influenza viruses. The dose of the quadrivalent subunit adjuvanted vaccine containing 5 µg of each antigen and 200 µg of the adjuvant provided a 100% survival rate in mice and significantly decreased lung viral titers (more than 3 lg TCID50) in the mouse model of influenza pneumonia.Conclusion. The quadrivalent subunit vaccine with the betulin-based corpuscular adjuvant demonstrates high immunogenicity in laboratory mice and provides protection against fatal pneumonia caused by the influenza A virus subtype H1N1.
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Pablo-Marcos, Daniel, Ana Rodríguez-Fernández, Mónica Gozalo, Jesús Agüero, Francisco Arnaiz de Las Revillas, and Jorge Calvo. "Description of Influenza B in seasonal epidemic in Cantabria during the beginning of the pandemia due to SARS-CoV-2." Revista Española de Quimioterapia 33, no. 6 (September 22, 2020): 444–47. http://dx.doi.org/10.37201/req/077.2020.
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Introduction. Co-circulation of the two Influenza B lineages hinders forecast of strain to include in trivalent vaccine. Autonomous Communities such as Cantabria continue without supplying tetravalent vaccine. The aim of this study was to analyse epidemiological characteristics of influenza type B in Cantabria (2019-2020 season) as well as to establish the predominant lineage and its relation to the recommended vaccine. Methods. Retrospective study whereby flu diagnosis and lineage analysis were determined by RT-PCR. Results. All samples belonged to the Victoria lineage. Most prevalent viral co-infection was due to SARS-CoV-2. The population affected by influenza B was mainly paediatric and non-vaccinated patients more frequently required hospital admittance. Conclusions. Influenza type B has a higher incidence in the paediatric population and type A affects more the adult population. Only 28.8% of patients with Influenza B that presented with some underlying condition or risk factor were vaccinated. This shows the need to increase coverage with tetravalent vaccines in order to reduce the burden of disease associated with the Influenza B virus.
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Prokopyeva, Elena, Olga Kurskaya, Ivan Sobolev, Mariia Solomatina, Tatyana Murashkina, Anastasia Suvorova, Alexander Alekseev, et al. "Experimental Infection Using Mouse-Adapted Influenza B Virus in a Mouse Model." Viruses 12, no. 4 (April 21, 2020): 470. http://dx.doi.org/10.3390/v12040470.
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Every year, influenza B viruses (IBVs) contribute to annual illness, and infection can lead to serious respiratory disease among humans. More attention is needed in several areas, such as increasing virulence or pathogenicity of circulating B viruses and developing vaccines against current influenza. Since preclinical trials of anti-influenza drugs are mainly conducted in mice, we developed an appropriate infection model, using an antigenically-relevant IBV strain, for furtherance of anti-influenza drug testing and influenza vaccine protective efficacy analysis. A Victoria lineage (clade 1A) IBV was serially passaged 17 times in BALB/c mice, and adaptive amino acid substitutions were found in hemagglutinin (HA) (T214I) and neuraminidase (NA) (D432N). By electron microscopy, spherical and elliptical IBV forms were noted. Light microscopy showed that mouse-adapted IBVs caused influenza pneumonia on day 6 post inoculation. We evaluated the illness pathogenicity, viral load, and histopathological features of mouse-adapted IBVs and estimated anti-influenza drugs and vaccine efficiency in vitro and in vivo. Assessment of an investigational anti-influenza drug (oseltamivir ethoxysuccinate) and an influenza vaccine (Ultrix®, SPBNIIVS, Saint Petersburg, Russia) showed effectiveness against the mouse-adapted influenza B virus.
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Postma, Maarten, Stephen I. Pelton, Victoria Divino, Joaquin F. Mould-Quevedo, Drishti Shah, and Mitchell DeKoven. "14. A Comprehensive Real-World Analysis to Compare Adjuvanted Trivalent Influenza Vaccine and Trivalent High Dose Influenza Vaccine by Age and Period of High Influenza Activity for the 2018–19 Season among U.S. Elderly." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S29—S30. http://dx.doi.org/10.1093/ofid/ofaa439.059.
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Abstract Background Influenza vaccine effectiveness decreases with increasing age due to the senescence of immune function and a reduced immune response to antigens. There is also considerable vaccine effectiveness heterogeneity depending on the influenza activity time period, especially in seasons where two different circulating strains predominated, such as the 2018–19 season. This research aimed to assess the effect of age and high influenza activity period (HIAP) on the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) vs. trivalent high-dose influenza vaccine (HD-TIV) among elderly (≥65y) recipients in the U.S. Methods During the 2018–19 influenza season, a retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. The first sub-analysis evaluated rVE for different age groups (65–74 years, 75–84 years, ≥85 years). The second sub-analysis evaluated rVE overall, restricting the observation period from to HAIP: Dec 2018-Mar 2019 (August 2018-July 2019 in the main analysis). Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE for influenza-related hospitalizations/emergency room (ER) visits and office visits. Results Following IPTW, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. Following IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (7.0%; 95% CI: 2.6%-11.2%) in the HIAP sub-analysis. In the age sub-analysis, the rVE favoring aTIV ranged from 5.1% (95% CI: -0.17%-10.1%) for the youngest group (65–74) up to 11.4% (95% CI: 0.6%-21.1%) for the eldest group (≥85y) for influenza-related office visits. No statistically significant differences were found for aTIV compared to TIV-HD for prevention of influenza-related hospitalizations/ER visits in the sub-analyses evaluated. Conclusion In adjusted analyses, aTIV reduced influenza-related office visits compared to TIV-HD within the two older age groups and HIAP sub-analysis. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant)
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Baranov, Konstantin V., Pei-Fong Wong, Ekaterina A. Stepanova, Ekaterina A. Bazhenova, Elena V. Krutikova, Irina N. Isakova-Sivak, and Larisa G. Rudenko. "Construction of the vaccine strain of the influenza B virus with chimeric hemagglutinin to induce a cross-protective immune response." Medical academic journal 21, no. 3 (December 6, 2021): 91–96. http://dx.doi.org/10.17816/maj77556.
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BACKGROUND: Influenza viruses cause worldwide epidemics, and the most effective method to prevent influenza disease is regular vaccinations. The development of new generation vaccines is aimed primarily at the formation of an immune response against a wide range of influenza viruses. One of the promising approaches is sequential vaccination with chimeric influenza viruses with identical stem domains of the hemagglutinin surface protein.
AIM: The development of an experimental vaccine strain of influenza B virus with chimeric hemagglutinin consisting of head and stem domains of influenza B viruses belonging to different genetic lineages.
MATERIALS AND METHODS: A chimeric influenza hemagglutinin gene was obtained by genetic engineering from the genetic material of B/Victoria and B/Yamagata influenza strains. The gene was inserted into the vector for the reverse genetics of the influenza virus. The influenza B virus strain with chimeric hemagglutinin was obtained by transfection of Vero cells using an 8-plasmid system. The rest of the genes were obtained from the attenuated influenza B virus with cold-adapted and temperature-sensitive phenotypes. The biological properties of the obtained recombinant strain, its infectious titer in developing chicken embryos and MDCK cell culture were evaluated.
RESULTS: A recombinant vaccine strain has been successfully rescued. The head domain of the hemagglutinin of the virus is inherited from the B/Victoria influenza virus, and the stem domain from the B/Yamagata virus. The virus actively replicated in eggs and MDCK cells, with temperature-sensitive and cold-adapted phenotypes identical to classical live attenuated influenza vaccine viruses. The thermal stability of the chimeric hemagglutinin did not differ significantly from the thermal stability of the hemagglutinins of the donor viruses.
CONCLUSIONS: The results obtained indicate the possibility of creating a strain with chimeric hemagglutinin, fragments of which are inherited from different genetic lineages. The growth characteristics and biological properties of the strain make it a promising candidate for the experimental evaluation of the possibility of inducing a cross-protective immune response by sequential vaccination with vaccine strains with identical stem hemagglutinin domains.
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Yatsyshina, S. B., A. N. Renteeva, A. V. Valdokhina, M. A. Elkina, A. S. Speranskaya, E. V. Pimkina, R. R. Mintaev, M. L. Markelov, and V. V. Maleev. "GENETIC CHARACTERISTICS OF INFLUENZA A/H3N2 AND В VIRUSES THAT HAD CIRCULATED IN RUSSIA IN 2013 - 2015." Journal of microbiology, epidemiology and immunobiology 93, no. 5 (October 28, 2016): 60–72. http://dx.doi.org/10.36233/0372-9311-2016-5-60-72.
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Aim. Establish genetic characteristics, carry out phylogenetic analysis and determination of molecular markers of resistance to etiotropic preparations against influenza A/H3N2 and В viruses that had circulated in Russia in 2013 - 2015. Materials and methods. 80 biological samples containing influenza A/H3N2 virus RNA and 31 samples containing influenza В virus RNA were studied. Sequencing of PCR fragments was carried out in ABI-3100 PRIZMTM GeneticAnalyzer (AppliedBiosystems, USA) and using MiSeq (Illumina, USA). Data treatment and analysis was carried out using CLC v.3.6.5., DNASTAR and BioNumerics v.6.5. programs. Results. In 2013 - 2014 A/Texas/50/2012-like clade 3C.3 influenza A/H3N2 viruses dominated, 10% belonged to subclade 3C.2a and 10% - to ЗС.ЗЬ. Most of the viruses (81%) of 2014 - 2015 were of 3C.2a clade, the portion of viruses belonging to ЗС.ЗЬ and ЗС.За was 9 and 10%. Yamagata-like viruses predominated among the studied influenza В viruses, only 1 virus of 2014 - 2015 belonged to Victoria lineage, 1 reassortant of Yamagata and Victoria lineages was detected. Rimantadine-resistance mutation S31N (М2 protein) was detected in all the influenza A/H3N2 viruses. Mutations determining resistance to oseltamivir (NA gene) were not detected in influenza A/H3N2 and В viruses. Conclusion. Increase of influenza morbidity in 2014 - 2015 was determined by the emergence of influenza A/H3N2 and В viruses, antigenically distinct from those that had circulated previously and those included into the vaccine, thus resulting in the WHO decision to change А/ H3N2 and В components of the 2015 - 2016 vaccine. Simultaneous circulation of 2 lineages of influenza В virus and emergence of their reassortants gives evidence on the necessity of use of quadrivalent vaccines, containing both lineages.
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Tram, Jennifer. "Use of Computational Matrix Adjustment to Evaluate the Effectiveness of Common Influenza Vaccines against the Emergence of Drift Variants." International Journal of Applied Sciences and Biotechnology 2, no. 3 (September 25, 2014): 224–28. http://dx.doi.org/10.3126/ijasbt.v2i3.10952.
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Every year the FDA issues a recommendation for the composition of the year’s common influenza vaccine for influenzas A and B. The FDA can consistently predict the dominance of a particular strand of influenza virus by taking into account previous years’ antigenic characterization percentages. However, the sudden disappearance of dominant antigens and the sudden emergence of drift variants can disrupt this pattern, which questions the effectiveness of that year’s vaccine. Basic Local Alignment Search Tool was used to compare the protein sequences for hemagglutinin and neuraminidase between the strands in the vaccine and the dominant viral strands. This study examined the effectiveness of vaccines from 2000 to 2012, focusing on the transitions between the B/Yamagata and B/Victoria lineages and A/New Caledonia and A/California lineages (H1N1). Between the years 2005 and 2006, dominance of the B/Yamagata lineage, represented by B/Shanghai/361/2002, disappeared almost entirely. For the 2005-2006 flu season, the CDC recommended a B/Shanghai/361/2002 vaccine which expressed a 98% identity to the dominant influenza B hemagglutinin sequence and a 97% identity to the dominant neuraminidase sequence. From 2007 to 2008, the A/New Caledonia virus declined to 34% of cases while the A/Solomon Islands/3/2006 virus increased to 66%. The A/New Caledonia/20/99 vaccine effectively expressed a 97% identity to the hemagglutinin sequence of A/Solomon Islands/3/2006 strand and a 98% identity to the neuraminidase sequence. This study demonstrates that from 2000 to 2012, despite drift variants in influenza viruses, the CDC-recommended vaccine effectively matches the hemagglutinin and neuraminidase protein sequences of the dominant viruses.DOI: http://dx.doi.org/10.3126/ijasbt.v2i3.10952 Int J Appl Sci Biotechnol, Vol. 2(3): 224-228
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L’vov, D. K., E. I. Burtseva, L. V. Kolobukhina, I. T. Fedyakina, N. V. Bovin, A. V. Ignatjeva, K. G. Krasnoslobodtsev, et al. "Peculiarities of the influenza and ARVI viruses circulation during epidemic season 2019–2020 in some regions of Russia." Problems of Virology 65, no. 6 (January 8, 2021): 335–49. http://dx.doi.org/10.36233/0507-4088-2020-65-6-4.
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Introduction. The surveillance of influenza viruses in ARVI structure and study of their properties in epidemic season 2019–2020 in Russian Federation are actual for investigations due to tasks of Global Influenza Strategy initiated by WHO in 2019.Material and methods. The data of epidemiological surveillance on influenza- and ARVI-associated morbidity and hospitalization in different age groups of population were analyzed; virological, genetic and statistical methods were used.Results. Preschool children were involved in epidemic the most. Meanwhile, the highest rate of hospitalization was observed in patients of 18–40 years old. Influenza A(H1N1)pdm09 virus dominated in etiology of ARVI in hospitalized patients and pneumonia. The role of respiratory viruses in severe cases of pneumonia and bronchoalveolar syndrome in children was shown. The differences in spectrum of circulating viruses caused ARVI in different regions of Russia were found. Influenza A(H1N1)pdm09 and B/Victoria-like viruses were the main etiological agents that caused of epidemic; its activity among all ARVI was 7.3 and 8.0%, respectively. The differences in antigenic properties of influenza A(H3N2) and B epidemic strains compared to vaccine viruses were found. The populations of epidemic strains were presented by following dominant genetic groups: 6B1.A5/183P for A(H1N1)pdm09, 3С.2а1b+137F for A(H3N2) and V1A.3 line B/Victoria-like for B viruses. The good profile of epidemic strains susceptibility to anti-neuraminidase inhibitors has been saved. The most of the studied influenza strains had the receptor specificity characteristic of human influenza viruses.Conclusions. Obtained results identified the peculiarities of viruses caused the influenza and ARVI in epidemic season 2019–2020 in different regions of Russia. These results suggested the important role of influenza A(H1N1) pdm09 in severe cases and pneumonia in adults 18–40 years old. The continuing drift in influenza viruses was found, which, apparently, could not but affect the efficacy of vaccine prophylaxis and was also considered in the recommendations of WHO experts on the composition of influenza vaccines for the countries of the Northern Hemisphere in the 2020–2021 season.
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L’vov, D. K., E. I. Burtseva, L. V. Kolobukhina, I. T. Fedyakina, N. V. Bovin, A. V. Ignatjeva, K. G. Krasnoslobodtsev, et al. "Peculiarities of the influenza and ARVI viruses circulation during epidemic season 2019–2020 in some regions of Russia." Problems of Virology 65, no. 6 (January 8, 2021): 335–49. http://dx.doi.org/10.36233/0507-4088-2020-65-6-4.
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Introduction. The surveillance of influenza viruses in ARVI structure and study of their properties in epidemic season 2019–2020 in Russian Federation are actual for investigations due to tasks of Global Influenza Strategy initiated by WHO in 2019.Material and methods. The data of epidemiological surveillance on influenza- and ARVI-associated morbidity and hospitalization in different age groups of population were analyzed; virological, genetic and statistical methods were used.Results. Preschool children were involved in epidemic the most. Meanwhile, the highest rate of hospitalization was observed in patients of 18–40 years old. Influenza A(H1N1)pdm09 virus dominated in etiology of ARVI in hospitalized patients and pneumonia. The role of respiratory viruses in severe cases of pneumonia and bronchoalveolar syndrome in children was shown. The differences in spectrum of circulating viruses caused ARVI in different regions of Russia were found. Influenza A(H1N1)pdm09 and B/Victoria-like viruses were the main etiological agents that caused of epidemic; its activity among all ARVI was 7.3 and 8.0%, respectively. The differences in antigenic properties of influenza A(H3N2) and B epidemic strains compared to vaccine viruses were found. The populations of epidemic strains were presented by following dominant genetic groups: 6B1.A5/183P for A(H1N1)pdm09, 3С.2а1b+137F for A(H3N2) and V1A.3 line B/Victoria-like for B viruses. The good profile of epidemic strains susceptibility to anti-neuraminidase inhibitors has been saved. The most of the studied influenza strains had the receptor specificity characteristic of human influenza viruses.Conclusions. Obtained results identified the peculiarities of viruses caused the influenza and ARVI in epidemic season 2019–2020 in different regions of Russia. These results suggested the important role of influenza A(H1N1) pdm09 in severe cases and pneumonia in adults 18–40 years old. The continuing drift in influenza viruses was found, which, apparently, could not but affect the efficacy of vaccine prophylaxis and was also considered in the recommendations of WHO experts on the composition of influenza vaccines for the countries of the Northern Hemisphere in the 2020–2021 season.
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Desheva, Yulia, Nadezhda Petkova, Tatiana Smolonogina, Svetlana Donina, and Alexey Go. "Study of Antibodies to Influenza Neuraminidase N2." Pharmaceuticals 15, no. 5 (April 19, 2022): 498. http://dx.doi.org/10.3390/ph15050498.
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Humoral immunity to influenza neuraminidase (NA) was evaluated among different groups of people including patients with acute influenza infection and healthy people in different age groups using an enzyme linked lectin assay (ELLA). The amino acid composition of NA of seasonal influenza viruses A/Victoria/361/2011(H3N2) and A/Hong Kong/4801/2014(H3N2) differed by 2%, while cross-reacting neuraminidase-inhibiting (NI) antibodies to them in the same serum samples were detected in 10% of cases. Middle-aged patients born from 1977 to 2000 had a high level of hemagglutination-inhibiting (HI) antibodies to A/Hong Kong/4801/2014(H3N2), but almost no NI antibodies, which may indicate that in the case of a change in the hemagglutinin (HA) subtype, this age group will be susceptible to influenza A/H3N2 viruses. Therefore, it could mean there is a need for priority vaccination of this age group with a vaccine against the appropriate strain. It was shown that after intranasal administration of live influenza vaccine (LAIV) for the 2017–2018 season, serum antibody response was not lower compared to that during natural infection. In older people, antibodies to archival A/H2N2 viruses were detected more often than to modern A/H3N2. Since the conversion of antibodies to HA and NA often did not coincide, antibodies to NA can serve as an additional criterion for assessing the immunogenicity of influenza vaccines.
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Nott, Rohini, Trevon L. Fuller, Patrícia Brasil, and Karin Nielsen-Saines. "Out-of-Season Influenza during a COVID-19 Void in the State of Rio de Janeiro, Brazil: Temperature Matters." Vaccines 10, no. 5 (May 23, 2022): 821. http://dx.doi.org/10.3390/vaccines10050821.
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An out-of-season H3N2 type A influenza epidemic occurred in the State of Rio de Janeiro, Brazil during October–November 2021, in between the Delta and Omicron SARS-CoV-2 surges, which occurred in July–October 2021 and January–April 2022, respectively. We assessed the contribution of climate change and influenza immunization coverage in this unique, little publicized phenomenon. State weather patterns during the influenza epidemic were significantly different from the five preceding years, matching typical winter temperatures, associated with the out-of-season influenza. We also found a mismatch between influenza vaccine strains used in the winter of 2021 (trivalent vaccine with two type A strains (Victoria/2570/2019 H1N1, Hong Kong/2671/2019 H3N2) and one type B strain (Washington/02/2019, wild type) and the circulating influenza strain responsible for the epidemic (H3N2 Darwin type A influenza strain). In addition, in 2021, there was poor influenza vaccine coverage with only 56% of the population over 6 months old immunized. Amid the COVID-19 pandemic, we should be prepared for out-of-season outbreaks of other respiratory viruses in periods of COVID-19 remission, which underscore novel disease dynamics in the pandemic era. The availability of year-round influenza vaccines could help avoid unnecessary morbidity and mortality given that antibodies rapidly wane. Moreover, this would enable unimmunized individuals to have additional opportunities to vaccinate during out-of-season outbreaks.
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Abo Shama, Noura M., Sara H. Mahmoud, Ola Bagato, Elsayed Tarek AbdElsalam, Maha Alkhazindar, Ahmed Kandeil, Pamela P. McKenzie, et al. "Incidence and neutralizing antibody seroprevalence of influenza B virus in Egypt: Results of a community-based cohort study." PLOS ONE 17, no. 6 (June 29, 2022): e0269321. http://dx.doi.org/10.1371/journal.pone.0269321.
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Since 2000, two lineages of influenza B viruses, Victoria and Yamagata, have been circulating at similar frequencies worldwide. Little is known about the circulation of those viruses in Egypt. This study aims to describe the epidemiology of influenza B virus infections in Egypt, 2017–2019. This was performed through a household prospective cohort study on influenza infections among 2400 individuals from five villages. When a study participant had influenza like symptoms, a nasal swab and an oropharyngeal swab were obtained and tested by RT-PCR for influenza B infections. A serum sample was obtained from all participants annually to detect neutralizing antibodies using microneutralization assay. 9.1% of subjects were positive for influenza B viruses during season 2017–2018 mostly among preschoolers and 7.6% were positive during the season 2018–2019 with higher risk in females, potentially due to mothers being infected after contact with their children. The overall seroprevalence among the participants was 53.2% and 52.2% against the Victoria and Yamagata lineages respectively, the majority of seropositive participants were students. Multivariate analysis showed that age and having chronic diseases were the strongest predictors of infection. Our results show that both influenza B lineages circulated between 2017 and 2020 in Egypt almost in equal proportion. Encouraging the uptake of seasonal influenza vaccines is recommended.
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Ramage, Walter, Tiziano Gaiotto, Christina Ball, Paul Risley, George W. Carnell, Nigel Temperton, Chung Y. Cheung, Othmar G. Engelhardt, and Simon E. Hufton. "Cross-Reactive and Lineage-Specific Single Domain Antibodies against Influenza B Hemagglutinin." Antibodies 8, no. 1 (February 10, 2019): 14. http://dx.doi.org/10.3390/antib8010014.
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Influenza B virus (IBV) circulates in the human population and causes considerable disease burden worldwide, each year. Current IBV vaccines can struggle to mount an effective cross-reactive immune response, as strains become mismatched, due to constant antigenic changes. Additional strategies which use monoclonal antibodies, with broad reactivity, are of considerable interest, both, as diagnostics and as immunotherapeutics. Alternatives to conventional monoclonal antibodies, such as single domain antibodies (NanobodiesTM) with well-documented advantages for applications in infectious disease, have been emerging. In this study we have isolated single domain antibodies (sdAbs), specific to IBV, using alpacas immunised with recombinant hemagglutinin (HA) from two representative viruses, B/Florida/04/2006 (B/Yamagata lineage) and B/Brisbane/60/2008 (B/Victoria lineage). Using phage display, we have isolated a panel of single domain antibodies (sdAbs), with both cross-reactive and lineage-specific binding. Several sdAbs recognise whole virus antigens, corresponding to influenza B strains included in vaccines spanning over 20 years, and were capable of neutralising IBV pseudotypes corresponding to prototype strains from both lineages. Lineage-specific sdAbs recognised the head domain, whereas, sdAbs identified as cross-reactive could be classified as either head binding or stem binding. Using yeast display, we were able to correlate lineage specificity with naturally occurring sequence divergence, at residue 122 in the highly variable 120 loop of the HA1 domain. The single domain antibodies described, might have applications in IBV diagnostics, vaccine potency testing and as immunotherapeutics.
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Carnell, George W., Claudia M. Trombetta, Francesca Ferrara, Emanuele Montomoli, and Nigel J. Temperton. "Correlation of Influenza B Haemagglutination Inhibiton, Single-Radial Haemolysis and Pseudotype-Based Microneutralisation Assays for Immunogenicity Testing of Seasonal Vaccines." Vaccines 9, no. 2 (January 28, 2021): 100. http://dx.doi.org/10.3390/vaccines9020100.
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Influenza B is responsible for a significant proportion of the global morbidity, mortality and economic loss caused by influenza-related disease. Two antigenically distinct lineages co-circulate worldwide, often resulting in mismatches in vaccine coverage when vaccine predictions fail. There are currently operational issues with gold standard serological assays for influenza B, such as lack of sensitivity and requirement for specific antigen treatment. This study encompasses the gold standard assays with the more recent Pseudotype-based Microneutralisation assay in order to study comparative serological outcomes. Haemagglutination Inhibition, Single Radial Haemolysis and Pseudotype-based Microneutralisation correlated strongly for strains in the Yamagata lineage; however, it correlated with neither gold standard assays for the Victoria lineage.
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Kiseleva, Irina, Elena Krutikova, Ekaterina Stepanova, Svetlana Donina, Maria Pisareva, Vera Krivitskaya, Andrey Rekstin, Erin Grace Sparrow, Guido Torelli, and Larisa Rudenko. "Cross-Protective Efficacy of Monovalent Live Influenza B Vaccines against Genetically Different Lineages of B/Victoria and B/Yamagata in Ferrets." BioMed Research International 2018 (August 30, 2018): 1–11. http://dx.doi.org/10.1155/2018/9695628.
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Background.Currently, two genetic lineages of influenza B virus, B/Victoria and B/Yamagata, are cocirculating in humans in various countries. This situation has raised a question regarding the possibility of cross-protection between B components of live attenuated influenza vaccine (LAIV) belonging to different lineages. This study aimed to assess in naïve ferrets the potential protective activity of monovalent B-LAIVs against challenge with homologous and heterologous wild-type (WT) influenza B viruses.Methods.Groups of seronegative female ferrets 5-6 months of age were given one dose of monovalent LAIV based on B/Victoria or B/Yamagata lineage virus. Ferrets were challenged 21 days later with B/Victoria or B/Yamagata WT virus. Ferrets were monitored closely for clinical signs and morbidity outcomes including febrile response, body weight loss, nasal symptoms, and level of activity one week prior to vaccination and for three days following vaccination/challenge. Nasal washes were collected three days after vaccination/challenge. Samples of lung tissue were taken three days after challenge. All samples were analyzed for the presence of challenge virus by culturing in embryonated chicken eggs and real-time polymerase chain reaction. Antibody response to vaccination was assessed by routine hemagglutination inhibition assay and microneutralization test.Results.Vaccination led to intensive production of specific neutralizing and antihemagglutinating antibodies to vaccine virus, protected ferrets from homologous challenge infection, and significantly reduced clinical signs and replication of homologous challenge virus. In contrast, cross-lineage serum antibodies were not detected. However, ferrets vaccinated with monovalent B-LAIV had a significantly lower level of heterologous challenge virus in the respiratory tract than those given challenge virus only.Conclusions.Monovalent B-LAIV has the potential to be cross-protective against infection with genetically different influenza lineages. Further studies are required to confirm this effect.
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Kobie, James, Michael Piepenbrink, Aitor Nogales, and Luis Martinez-Sobrido. "Induction and isolation of protective influenza neuraminidase specific antibodies in humans following seasonal vaccination." Journal of Immunology 200, no. 1_Supplement (May 1, 2018): 60.17. http://dx.doi.org/10.4049/jimmunol.200.supp.60.17.
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Abstract Influenza’s propensity for antigenic drift and shift, and to elicit predominantly strain specific antibodies (Abs) leaves humanity susceptible to waves of new strains with pandemic potential for which limited or no immunity may exist. Subsequently new clinical interventions are needed, particularly those with broad activity against diverse strains. Although hemagglutinin (HA) specificity dominates the humoral response to seasonal inactivated influenza vaccines and infection, Abs targeting neuraminidase (NA) are also generated. NA-specific Abs are suggested to act primarily through inhibiting its enzymatic activity and preventing release of virus from infected cells. Relative to HA, there is substantially less diversity among NA from different influenza types and subtypes, suggesting it is a valuable target for inducing broad protective immunity. To determine if humans generate NA-specific Abs with protective activity we examined plasmablasts from subjects that were immunized with the seasonal influenza inactivated vaccine, and isolated several NA-specific human monoclonal Abs (hmAbs), including those with potent in vitro viral neutralizing activity. One of the NA B–specific hmAbs, KPF2 recognized NA from both the Yamagata and Victoria lineages, and when administered prophylactically to mice resulted in sterilizing immunity. These results suggest seasonal influenza vaccine induces protective NA-specific mAbs in humans. Analysis of other NA-specific hmAbs is ongoing.
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Chang, Lee-Jah, Ya Meng, Helene Janosczyk, Victoria Landolfi, and H. Keipp Talbot. "LB14. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older." Open Forum Infectious Diseases 5, suppl_1 (November 2018): S764. http://dx.doi.org/10.1093/ofid/ofy229.2188.
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Abstract Background Older adults (≥65 years of age) remain at increased risk of influenza because they do not respond to standard dose influenza vaccines as well as younger adults. A high dose, inactivated trivalent influenza vaccine, IIV3-HD, containing four times the antigen content (60 µg hemagglutinin per influenza strain) of standard-dose influenza vaccines has been available in the United States since 2010. Two distinct B influenza lineages (Victoria and Yamagata) have co-circulated for over a decade, making it difficult to predict which will predominate the next season. IIV4-HD has been developed to address the frequent influenza B strain mismatches by incorporating a strain from each B lineage. This pivotal Phase III study evaluated the safety and immunogenicity of IIV4-HD as compared with two IIV3-HD vaccines. Method A randomized, modified double-blind, multicenter study (NCT03282240) was conducted in 2670 healthy subjects in the United States, who were randomly assigned to receive IIV4-HD, a licensed IIV3-HD, or an IIV3-HD with the alternate B influenza strain. Using the hemagglutinin inhibition (HAI) assay at baseline and 28 days after vaccination, post-vaccination geometric mean titers and seroconversion rates were measured. Safety data were collected through 6 months post-vaccination. Result IIV4-HD was noninferior to the licensed IIV3-HD and the investigational IIV3-HD (containing the alternate B strain) for all four influenza strains as assessed by HAI GMTs and seroconversion rates. Moreover, IIV4-HD induced a superior immune response (HAI GMTs and seroconversion rates) compared with the immune response induced by the IIV3-HD that does not contain the corresponding B strain. Reactogenicity profiles were comparable across all study groups. Most unsolicited adverse events were of Grade 1 or Grade 2 intensity. One serious adverse event considered related by the Investigator was reported in the IIV4-HD group. Conclusion Vaccination of adults 65 years of age and older with IIV4-HD was found to be noninferior to two IIV3-HD vaccines with a similar safety profile. The addition of a second B lineage strain does not adversely affect the safety or immunogenicity profile of IIV4-HD compared with IIV3-HD. Disclosures L. J. Chang, Sanofi Pasteur: Employee, Salary. Y. Meng, Sanofi Pasteur: Employee, Salary. H. Janosczyk, Sanofi Pasteur: Employee, Salary. V. Landolfi, Sanofi Pasteur: Employee, Salary. H. K. Talbot, Sanofi Pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.
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Durviaux, Serge, John Treanor, Jiri Beran, Xavier Duval, Meral Esen, Gregory Feldman, Sharon E. Frey, et al. "Genetic and Antigenic Typing of Seasonal Influenza Virus Breakthrough Cases from a 2008-2009 Vaccine Efficacy Trial." Clinical and Vaccine Immunology 21, no. 3 (December 26, 2013): 271–79. http://dx.doi.org/10.1128/cvi.00544-13.
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ABSTRACTEstimations of the effectiveness of vaccines against seasonal influenza virus are guided by comparisons of the antigenicities between influenza virus isolates from clinical breakthrough cases with strains included in a vaccine. This study examined whether the prediction of antigenicity using a sequence analysis of the hemagglutinin (HA) gene-encoded HA1 domain is a simpler alternative to using the conventional hemagglutination inhibition (HI) assay, which requires influenza virus culturing. Specimens were taken from breakthrough cases that occurred in a trivalent influenza virus vaccine efficacy trial involving >43,000 participants during the 2008-2009 season. A total of 498 influenza viruses were successfully subtyped as A(H3N2) (380 viruses), A(H1N1) (29 viruses), B(Yamagata) (23 viruses), and B(Victoria) (66 viruses) from 603 PCR- or culture-confirmed specimens. Unlike the B strains, most A(H3N2) (377 viruses) and all A(H1N1) viruses were classified as homologous to the respective vaccine strains based on their HA1 domain nucleic acid sequence. HI titers relative to the respective vaccine strains and PCR subtyping were determined for 48% (182/380) of A(H3N2) and 86% (25/29) of A(H1N1) viruses. Eighty-four percent of the A(H3N2) and A(H1N1) viruses classified as homologous by sequence were matched to the respective vaccine strains by HI testing. However, these homologous A(H3N2) and A(H1N1) viruses displayed a wide range of relative HI titers. Therefore, although PCR is a sensitive diagnostic method for confirming influenza virus cases, HA1 sequence analysis appeared to be of limited value in accurately predicting antigenicity; hence, it may be inappropriate to classify clinical specimens as homologous or heterologous to the vaccine strain for estimating vaccine efficacy in a prospective clinical trial.
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Mir, Hyder, Inaamul Haq, and Parvaiz A. Koul. "Poor Vaccine Effectiveness against Influenza B-Related Severe Acute Respiratory Infection in a Temperate North Indian State (2019–2020): A Call for Further Data for Possible Vaccines with Closer Match." Vaccines 9, no. 10 (September 28, 2021): 1094. http://dx.doi.org/10.3390/vaccines9101094.
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Background: Influenza vaccine uptake in India is poor, and scant data exist regarding the effectiveness of influenza vaccine against hospitalization. Methods: From October 2019 to March 2020, vaccination status of 1219 patients (males n = 571, aged 5–107 years; median, 50 years) hospitalized with severe acute respiratory illness (SARI) was assessed. The patients were tested for influenza viruses and their subtypes by RT PCR. Sequencing of the HA gene was performed. Vaccine effectiveness (VE) against influenza subtypes was estimated by the test negative design. Results: A total of 336 (27.5%) patients were influenza-positive, with influenza B/Victoria accounting for 49.7% (n = 167), followed by influenza A/H1N1 (47.6%; n = 155) and influenza A/H3N2 (4.4%; n = 15). About 6.8% and 8.6% of the influenza-positive and influenza-negative patients, respectively, had been vaccinated. Adjusted VE for any influenza strain was 13% (95% CI −42 to 47), which for influenza B was 0%. HA sequencing revealed that influenza B samples mainly belonged to subclade V1A.3/133R with deletion of residues 163–165, as against the 2-aa deletion in influenza B/Colorado/06/2017 strain, contained in the vaccine. VE for influenza A/H1N1 was 55%. Conclusions: Poor VE due to a genetic mismatch between the circulating strain and the vaccine strain calls for efforts to reduce the mismatch.
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Pemberton, R. M., R. Jennings, and T. L. Smith. "Morphology and antigenicity studies on reassortant influenza (H3N2) viruses for use in inactivated vaccines." Journal of Hygiene 94, no. 2 (April 1985): 229–39. http://dx.doi.org/10.1017/s002217240006143x.
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SUMMARYThree influenza A (H3N2) reassortant whole virus vaccine strains with differing antibody-inducing capacities in hamsters were investigated morphologically and antigenically. Although initial measurements of virion circumference, from electron micrographs of vaccine preparations, suggested a relationship of small virion size with low immunogenicity, subsequent immunization with, and morphological investigation of, vaccine virions separated on sucrose gradients, failed to obtain populations whose antibody-inducing capacity clearly correlated with constituent virion density, size, morphology or integrity.However, antigenic investigation using single radial haemolysis (SRH) and monoclonal antibodies revealed significant differences in antigenic specificity between the strains. Furthermore, a series of H3N2 isolates, derived using standard reassortment procedures, also showed differences in antigenic specificity in their haemagglutination-inhibition (HI) reactions with monoclonal antibodies after five passages in allantois-on-shell cultures. Variation between these isolates and their A/Victoria parent virus could be detected using SRH and hamster sera raised against each isolate.These results demonstrate variation between candidate influenza A virus vaccine strains, all possessing the same surface (H3N2) glycoproteins, expressed as a consequence of the reassortant system used for their production.
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Martinet, W., T. Deroo, X. Saelens, E. Beirnaert, P. Vanlandschoot, R. Contreras, W. Fiers, and W. Min Jou. "Evaluation of recombinant A/Victoria/3/75 (H3N2) influenza neuraminidase mutants as potential broad-spectrum subunit vaccines against influenza A." Archives of Virology 143, no. 10 (October 1998): 2011–19. http://dx.doi.org/10.1007/s007050050437.
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Stepanova, Ekaterina, Elena Krutikova, Pei-Fong Wong, Victoria Matyushenko, Ekaterina Bazhenova, Irina Isakova-Sivak, and Larisa Rudenko. "Safety, Immunogenicity, and Protective Efficacy of a Chimeric A/B Live Attenuated Influenza Vaccine in a Mouse Model." Microorganisms 9, no. 2 (January 27, 2021): 259. http://dx.doi.org/10.3390/microorganisms9020259.
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Influenza A and B viruses cause significant morbidity and mortality worldwide. Current influenza vaccines are composed of three or four strains: A/H1N1, A/H3N2, and B (Victoria and Yamagata lineages). It is of great interest if immunization against both type A and B influenza viruses can be combined in a single vaccine strain, thus reducing the cost of vaccine production and the possibility of strain interference within the multicomponent vaccine. In the current study, we developed an experimental live cold-adapted influenza intertype reassortant (influenza A and B) vaccine on the live attenuated influenza vaccine (LAIV) A/Leningrad/134/17/57 backbone. Hemagglutinin (HA) and neuraminidase (NA) functional domains were inherited from the influenza B/Brisbane/60/2008 strain, whereas their packaging signals were substituted with appropriate fragments of influenza A virus genes. The recombinant A/B virus efficiently replicated in eggs and Madin–Darby Canine Kidney (MDCK) cells under optimal conditions, temperature-sensitive phenotype was maintained, and its antigenic properties matched the influenza B parental virus. The chimeric vaccine was attenuated in mice: after intranasal immunization, viral replication was seen only in nasal turbinates but not in the lungs. Immunological studies demonstrated the induction of IgG antibody responses against the influenza A and B virus, whereas hemagglutination inhibition (HAI) and neutralizing antibodies were detected only against the influenza B virus, resulting in significant protection of immunized animals against influenza B virus challenge. IFNγ-secreting CD8 effector memory T cells (CD44+CD62L−) were detected in mouse splenocytes after stimulation with the specific influenza A peptide (NP366); however, the T-cell response was not sufficient to protect animals against infection with a high-dose mouse-adapted A/California/07/2009 (H1N1pdm09) virus, most probably due to the mismatch of key T-cell epitopes of the H1N1 virus and the LAIV backbone. Overall, generation of the chimeric A/B LAIV virus on a licensed LAIV backbone demonstrated prospects for the development of safe and efficacious vaccine candidates that afford combined protection against both type A and type B influenza viruses; however, further optimization of the T-cell epitope content within the LAIV backbone may be required.
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Rudakova, A. V., D. M. Danilenko, D. A. Lioznov, L. S. Karpova, S. M. Kharit, E. V. Mikitenko, A. N. Uskov, A. S. Kolbin, L. N. Konovalova, and Yu V. Lobzin. "INFLUENZA VACCINATION OF CHILDREN OF PRESCHOOL AGE IN THE RUSSIAN FEDERATION: COST-EFFECTIVENESS OF QUADRIVALENT VACCINE." Journal Infectology 11, no. 1 (March 30, 2019): 92–97. http://dx.doi.org/10.22625/2072-6732-2019-11-1-92-97.
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According to requirements of WHO, the trivalent influenza vaccines (TIV) have to contain antigens of two influenza A strains (A/H1N1, A/H3N2) and one influenza B strain which can be presented by antigens of a virus of lineages Yamagata or Victoria. In a season of 2017/2018 the discrepancy of the vaccinal and circulating influenza B strains was noted that caused decrease in effectiveness of vaccination, especially at children’s age when the frequency of detection of influenza B is higher, than in other age groups. Now in the Russian Federation it is registered, in addition to TIV, quadrivalent vaccine (QIV) manufactured in the Russian Federation and including antigens of influenza B viruses of the two lineages.The purpose of work was assessment of the cost-effectiveness of QIV in comparison with TIV at children of preschool age on the basis of epidemiological data on the Russian Federation for a season of 2017/2018.Material and methods. The analysis was carried out by a modeling method from a health care system and societal perspective taking into account epidemiological data on the Russian Federation and the European data on effectiveness of TIV at citizens of various age. Indirect effect of vaccination was not considered. The cost of the TIV and QIV (Grippol plus and Grippol quadrivalent, respectively) corresponded to the registered price including VAT.Results. The analysis showed that use QIV instead of TIV for children of preschool age in an epidemiological season of 2017/2018 would allow to increase quantity of the prevented influenza cases by 17.1%. The prevented indirect costs exceed the prevented direct medical costs. The incremental cost-effectiveness ratio (ICER) is 1042.65-1093.7 thousand rubles/QALY in the analysis from the health care system perspective and 124.50-267.91 thousand rubles/QALY in the analysis from the societal perspective.Conclusions. Vaccination against influenza of children of preschool age in the Russian Federation in a season of 2017/2018 with quadrivalent vaccine would allow to increase significantly the number of the prevented cases of disease and could be considered as economically highly effective intervention. Reduction of vaccine price less, than for 5% in comparison with the registered price would allow to avoid completely additional budget burden.
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Hill-Batorski, Lindsay, Yasuko Hatta, Michael Moser, David Marshall, and Pamuk Bilsel. "10. Quadrivalent M2SR (M2-deficient Single Replication) Live Influenza Vaccine Provides Better Protection Than Inactivated Vaccine Against Drifted Influenza B Virus Challenge in Ferrets." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S128—S129. http://dx.doi.org/10.1093/ofid/ofab466.212.
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Abstract Background Quadrivalent inactivated influenza vaccines (QIV) induce neutralizing antibodies (Abs) against the viral hemagglutinin (HA). Despite annual update of HA vaccine antigens to match circulating strains, current vaccines provide ~60% vaccine effectiveness (VE). QIV VE can be as low as 10% when circulating strains do not match vaccine HA. The live M2SR (M2-deficient single replication) influenza vaccine candidate has previously shown broad humoral, mucosal and cellular immune responses and protection against multiple influenza A subtypes. Here we show similar properties with the Quadrivalent M2SR (Quad M2SR) against drifted influenza B challenge in comparison to QIV. Methods Ferrets pre-infected with influenza H1N1 and B/Yamagata viruses, were immunized intranasally (IN) with PBS (Mock) or Quad M2SR, or intramuscularly with Fluzone QIV. Serum collected post-vaccination was evaluated for Ab responses. Forty-two days after vaccination, ferrets were challenged IN with 106 pfu of B/Brisbane/60/2008 (Victoria lineage) influenza virus. Nasal washes were taken for 7 days post-challenge and evaluated for challenge virus by TCID50 assay. Nasal turbinates, trachea and lungs were also evaluated for virus. Results Quad M2SR and QIV elicited high serum Abs against the vaccine strain B/Colorado/06/2017 (Fig. 1A) and against the drifted influenza B challenge strain B/Brisbane/60/2008 (Fig. 1B) in ferrets with preexisting immunity. Like Mock, ferrets who received QIV displayed both weight loss (6.2%, Fig. 2A) and a rise in temperature (1.1oC, Fig. 2B) after challenge. In contrast, the Quad M2SR group did not exhibit any significant weight or temperature changes after challenge. Quad M2SR controlled the drifted challenge virus better than QIV as evidenced by significantly lower or absent post-challenge virus titer in nasal washes (Fig. 3A) and nasal turbinates (Fig. 3B). Figure 1. Serum Neutralization Titers Post-Vaccination Plaque reduction neutralization test (PRNT) antibody titers for Quad M2SR and QIV against matched Influenza B vaccine strain B/Colorado/06/2017 (Fig. 1A) and drifted strain B/Brisbane/60/2008 (Fig. 1B) on pre-study (Day -3), pre-vaccination (Day 28), and 3 weeks post vaccination (Day 51). The detection limit of the assay (horizontal dashed line) was 15 PRNT50. Figure 2. Post-challenge body weight and temperature changes Percent body weight changes (Fig. 2A) and average body temperatures changes (Fig. 2B) following challenge with drifted Influenza B strain B/Brisbane/60/2008 for ferrets vaccinated with Quad M2SR or QIV. Figure 3. Post-challenge virus titers in respiratory tract. Viral titers in nasal washes (Fig. 3A) and nasal turbinates (Fig. 3B) collected post-challenge with Influenza B strain B/Brisbane/60/2008 in ferrets vaccinated with Quad M2SR or QIV. No virus was detected in the trachea or lungs. The detection limit of the assay (horizontal dashed line) was 1.5 log10 TCID50/mL and 20 FFU respectively. Virus titer between groups was significant on day 3 of the nasal washes: one-way analysis of variance (ANOVA) with Multiple t tests to compare between groups, #p<0.05,><0.01,><> Conclusion Despite eliciting similar Ab titers, the Quad M2SR demonstrated superior protection compared to QIV in a drifted influenza B challenge model in ferrets. These results suggest that the intranasal M2SR platform may confer additional advantages over currently available vaccines. Quad M2SR is in late-stage development for testing in a first-in-human clinical study. Disclosures Lindsay Hill-Batorski, PhD, FluGen (Employee) Yasuko Hatta, DVM, PhD, FluGen (Employee) Michael Moser, PhD, FluGen (Employee) David Marshall, BS, FluGen (Employee) Pamuk Bilsel, PhD, FluGen (Employee)
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Guzman Holst, Adriana, Luis Gilberto Gomez, Maria Yolanda Cervantes Apolinar, and Gloria Huerta. "1667. Influenza A and B Co-Circulation and Burden: A 2018–2019 Influenza Season Analysis Using the National Active Surveillance Database in Mexico." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S609—S610. http://dx.doi.org/10.1093/ofid/ofz360.1531.
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Abstract Background Seasonal influenza is a prevalent respiratory infection for children and adults in Mexico. Influenza A and B viruses co-circulate and there is a need to better understand local epidemiology to inform vaccination recommendations (tri- vs. quadrivalent vaccines). We describe the 2018–2019 influenza season to estimate influenza burden, virus co-circulation and understand the vaccine match in Mexico. Methods We reviewed preliminary sentinel surveillance data for the influenza season (October 2018–May 2019) from the Mexican Health Secretariat and World Health Organization’s (WHO) FluNet databases. We performed a descriptive analysis of cases and deaths due to influenza-like illness (ILI), severe acute respiratory infections (SARI) and lab-confirmed influenza to estimate the prevalence of influenza A and B circulating strains, per state and age group, and determine B strain vaccine match. Results During the 2018–2019 season in Mexico, there were 52,525 reported cases of ILI/SARI with 6,997 lab-confirmed influenza cases (28% positivity rate among ILI/SARI) and 787 (11%) deaths (Figures 1 and 2). The states with 36% of cases were Mexico City, State of Mexico, Hidalgo, Tlaxcala, and Guanajuato. More than half of the Mexican states had a high (10–14.9%) to intense (≥15%) accumulated case positivity rate of confirmed influenza in relation to ILI/SARI cases (Figure 3). Most cases were reported among the 1–9 and > 60-year-old groups. 45% of deaths occurred in State of Mexico, Hidalgo, Mexico City, Puebla, and Guanajuato. The seasonal viral profile was dominated by A/H1N1 (68%), followed by B (16%) and A/H3N2 (12%), with 90% of deaths attributed to A/H1N1. FluNet’s influenza B data show Yamagata (55%) and Victoria (27%) co-circulation (Figure 1). Conclusion The 2018–2019 seasonal co-circulation of influenza A and B viruses in Mexico showed significant nation-wide morbi-mortality burden, with A/H1N1 and B/Yamagata dominance. Stronger B lineage determination is needed in Mexico to understand associated burden and prevent vaccine mismatch, considering the trivalent vaccine does not contain both B strains. Given the circulation of both influenza B lineages and the recommendation of the WHO, Mexico could enhance quadrivalent vaccine use in coming seasons to optimize protection. Disclosures All authors: No reported disclosures.
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Colman, Peter M., and Antony W. Burgess. "Colin Wesley Ward 1943–2017." Historical Records of Australian Science 29, no. 2 (2018): 191. http://dx.doi.org/10.1071/hr17020.
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Colin Wesley Ward's professional life played out at the Commonwealth Scientific and Industrial Research Organisation (CSIRO) laboratory on Royal Parade, Parkville, Victoria, where he was a scientist, leader, raconteur, colleague and friend to several generations of staff who worked there. Ward's scientific legacy encompasses large bodies of work on antigenic variation in influenza viruses, the taxonomy of plant viruses, veterinary vaccines and the structure and function of several growth factor receptors. On retirement from CSIRO he continued work on the insulin receptor with colleagues at the Walter and Eliza Hall Institute of Medical Research, conceived of and founded CSIRO pedia and compiled his family history.
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Divino, Victoria, Maarten Postma, Stephen I. Pelton, Joaquin F. Mould-Quevedo, Ruthwik Anupindi, Mitchell DeKoven, and myron J. levin. "96. Relative Vaccine Effectiveness Against Influenza-Related and Any Respiratory-Related Hospital Encounter During the 2019/20 High Influenza Activity Period: A Comprehensive Real-World Analysis to Compare Quadrivalent Cell-based and Egg-based Influenza Vaccines." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S61. http://dx.doi.org/10.1093/ofid/ofab466.096.
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Abstract Background Changes in the influenza hemagglutinin protein during replication of influenza in eggs during vaccine production may contribute to low vaccine effectiveness (VE). This phenomenon, egg adaptation, can explain VE differences between egg-based (QIVe-SD) and cell-based (QIVc) quadrivalent influenza vaccines. This research evaluated the relative vaccine effectiveness (rVE) of QIVc versus QIVe-SD in the reduction of influenza-related and any respiratory-related hospitalizations/emergency room (ER) visits among subjects 4-64 years old during the 2019/20 influenza season. Methods A retrospective cohort analysis was conducted among subjects 4-64 years old vaccinated with QIVc or QIVe-SD using administrative claims data in the U.S. (IQVIA PharMetrics® Plus). The adjusted number of events and rates of influenza-related hospitalizations/ER visits and respiratory-related hospitalizations/ER visits were assessed using inverse probability of treatment weighting (IPTW). Poisson regression was used to estimate relative vaccine effectiveness (rVE). In the main analysis, the study period was from Aug 4, 2019 to Mar 7, 2020 (ending early to avoid any influenza outcome misclassification with COVD-19 infection). In the assessment of the high influenza activity period (HIAP), the analysis period was restricted to Dec 8, 2019 to Mar 7, 2020. Results During the 2019/20 influenza season, 1,150,134 recipients of QIVc and 3,924,819, of QIVe-SD were identified following IPTW. In the main analysis, adjusted results show that QIVc was associated with a significantly higher rVE compared to QIVe-SD against influenza-related hospitalizations/ER visits (5.3% [95%CI: 0.5%-9.9%]) and respiratory-related hospitalizations/ER visits (8.2% [95%CI: 6.5%-9.8%]). Similarly, in the HIAP analysis, QIVc was associated with a significantly higher rVE compared to QIVe-SD for influenza-related hospitalizations/ER visits (5.7% [95%CI: 0.8%-10.4%]) and respiratory-related hospitalizations/ER visits (7.3% [95%CI: 5.4%-9.2%]). Conclusion QIVc was more effective in preventing influenza-related and respiratory-related hospitalizations/ER visits compared to QIVe-SD, using either a broad influenza season definition or restricting to the HIAP. Disclosures Victoria Divino, PhD, Seqirus (Consultant) Maarten Postma, Dr., Seqirus (Consultant) Stephen I. Pelton, MD, Seqirus (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus (Employee) Ruthwik Anupindi, PhD, Seqirus (Consultant) Mitchell DeKoven, PhD, Seqirus (Consultant) myron J. levin, MD, GSK group of companies (Employee, Research Grant or Support)
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Falcón, Ana M., Ana Fernandez-Sesma, Yurie Nakaya, Thomas M. Moran, Juan Ortín, and Adolfo García-Sastre. "Attenuation and immunogenicity in mice of temperature-sensitive influenza viruses expressing truncated NS1 proteins." Journal of General Virology 86, no. 10 (October 1, 2005): 2817–21. http://dx.doi.org/10.1099/vir.0.80991-0.
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It was previously shown that two mutant influenza A viruses expressing C-terminally truncated forms of the NS1 protein (NS1-81 and NS1-110) were temperature sensitive in vitro. These viruses contain HA, NA and M genes derived from influenza A/WSN/33 H1N1 virus (mouse-adapted), and the remaining five genes from human influenza A/Victoria/3/75 virus. Mice intranasally infected with the NS1 mutant viruses showed undetectable levels of virus in lungs at day 3, whereas those infected with the NS1 wild-type control virus still had detectable levels of virus at this time. Nevertheless, the temperature-sensitive mutant viruses induced specific cellular and humoral immune responses similar to those induced by the wild-type virus. Mice immunized with the NS1 mutant viruses were protected against a lethal challenge with influenza A/WSN/33 virus. These results indicate that truncations in the NS1 protein resulting in temperature-sensitive phenotypes in vitro correlate with attenuation in vivo without compromising viral immunogenicity, an ideal characteristic for live attenuated viral vaccines.
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Elsherif, May, Todd Hatchette, Jason Leblanc, Lingyun Ye, Melissa K. Andrew, Ardith Ambrose, Guy Boivin, et al. "Epidemiology of Influenza Viruses in Canada over the 2011–2012 to 2013–2014 Seasons: A Study from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN)." Open Forum Infectious Diseases 4, suppl_1 (2017): S314. http://dx.doi.org/10.1093/ofid/ofx163.735.
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Abstract Background Influenza virus activity varies seasonally and within season. Epidemiology of serious influenza outcomes is contingent on the prevalent circulating strain/s and susceptible age group/s. Given the strain variability over the 2011–2012 through 2013–2014 seasons in Canada, this study examined the clinical and epidemiological profiles of different influenza strains causing adult hospitalizations. Methods During these three influenza seasons, the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) enrolled adults hospitalized with acute respiratory illness across Canada. Nasopharyngeal swabs (NPs) from influenza cases were tested for strain characterization using real-time reverse transcriptase polymerase chain reaction (rtRT-PCR). A primary assay differentiated A and B influenza viruses. Subsequently, influenza A viruses were subtyped as H1N1 or H3N2, and influenza B lineages were differentiated as Victoria or Yamagata. Laboratory results were compared with patient demographic data and clinical outcomes. Results Over three consecutive influenza seasons, 3394 cases of hospitalized acute respiratory illness were laboratory-confirmed as influenza. At 72.4%, influenza A was predominant across all seasons, while influenza B caused 27.6%. Most of the influenza A cases were due to H3N2 (58.7%), while H1N1 accounted for 41.3%. For influenza B, the Yamagata lineage was predominant at 88.4% whereas the Victoria lineage accounted for 11.6%. Outcome analyses are presented for each influenza A subtype and influenza B lineage, overall and per season. Considering serious outcomes in patients ≥65, higher proportions of patients hospitalized with the H1N1 strain experienced intensive care unit (ICU) admission and need for mechanical ventilation, while higher proportions of patients hospitalized with B/Yamagata and H3N2 died within 30 days of admission. Conclusion Comprehensive collection of surveillance data paired with NP specimens by the CIRN SOS Network was conducive to broader understanding of influenza strain activity and associated outcomes at the subtype and lineage level. This data is important to make informed recommendations for the use of multicomponent influenza vaccines. Disclosures M. Elsherif, Canadian Institutes of Health Research: Investigator, Research grant. Public Health Agency of Canada: Investigator, Research grant. GSK: Investigator, Research grant. T. Hatchette, GSK: Grant Investigator, Grant recipient; Pfizer: Grant Investigator, Grant recipient. Abbvie: Speaker for a talk on biologics and risk of TB reactivation, Speaker honorarium.M. K. Andrew, GSK: Grant Investigator, Research grant. Pfizer: Grant Investigator, Research grant. Sanofi-Pasteur: Grant Investigator, Research grant. J. McElhaney, GSK Vaccines: Scientific Advisor, Speaker honorarium. A. Mcgeer, Hoffman La Roche: Investigator, Research grant. GSK: Investigator, Research grant. sanofi pasteur: Investigator, Research grant. J. Powis, Merck: Grant Investigator, Research grant. GSK: Grant Investigator, Research grant. Roche: Grant Investigator, Research grant. Synthetic Biologicals: Investigator, Research grant. M. Semret, GSK: Investigator, Research grant. Pfizer: Investigator, Research grant. S. Trottier, Canadian Institutes of Health Research: Investigator, Research grant. L. Valiquette, GSK: Investigator, Research grant. S. McNeil, GSK: Contract Clinical Trials and Grant Investigator, Research grant. Merck: Contract Clinical Trials and Speaker’s Bureau, Speaker honorarium. Novartis: Contract Clinical Trials, No personal renumeration. sanofi pasteur: Contract Clinical Trials, No personal renumeration
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Keskin, Derin B., Bruce B. Reinhold, Guang Lan Zhang, Alexander R. Ivanov, Barry L. Karger, and Ellis L. Reinherz. "Physical detection of influenza A epitopes identifies a stealth subset on human lung epithelium evading natural CD8 immunity." Proceedings of the National Academy of Sciences 112, no. 7 (February 2, 2015): 2151–56. http://dx.doi.org/10.1073/pnas.1423482112.
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Vaccines eliciting immunity against influenza A viruses (IAVs) are currently antibody-based with hemagglutinin-directed antibody titer the only universally accepted immune correlate of protection. To investigate the disconnection between observed CD8 T-cell responses and immunity to IAV, we used a Poisson liquid chromatography data-independent acquisition MS method to physically detect PR8/34 (H1N1), X31 (H3N2), and Victoria/75 (H3N2) epitopes bound to HLA-A*02:01 on human epithelial cells following in vitro infection. Among 32 PR8 peptides (8–10mers) with predicted IC50 < 60 nM, 9 were present, whereas 23 were absent. At 18 h postinfection, epitope copies per cell varied from a low of 0.5 for M13–11 to a high of >500 for M158–66 with PA, HA, PB1, PB2, and NA epitopes also detected. However, aside from M158–66, natural CD8 memory responses against conserved presented epitopes were either absent or only weakly observed by blood Elispot. Moreover, the functional avidities of the immunodominant M158–66/HLA-A*02:01-specific T cells were so poor as to be unable to effectively recognize infected human epithelium. Analysis of T-cell responses to primary PR8 infection in HLA-A*02:01 transgenic B6 mice underscores the poor avidity of T cells recognizing M158–66. By maintaining high levels of surface expression of this epitope on epithelial and dendritic cells, the virus exploits the combination of immunodominance and functional inadequacy to evade HLA-A*02:01-restricted T-cell immunity. A rational approach to CD8 vaccines must characterize processing and presentation of pathogen-derived epitopes as well as resultant immune responses. Correspondingly, vaccines may be directed against “stealth” epitopes, overriding viral chicanery.
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Plant, Ewan P., Hasmik Manukyan, Jose L. Sanchez, Majid Laassri, and Zhiping Ye. "Immune Pressure on Polymorphous Influenza B Populations Results in Diverse Hemagglutinin Escape Mutants and Lineage Switching." Vaccines 8, no. 1 (March 11, 2020): 125. http://dx.doi.org/10.3390/vaccines8010125.
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Mutations arise in the genomes of progeny viruses during infection. Mutations that occur in epitopes targeted by host antibodies allow the progeny virus to escape the host adaptive, B-cell mediated antibody immune response. Major epitopes have been identified in influenza B virus (IBV) hemagglutinin (HA) protein. However, IBV strains maintain a seasonal presence in the human population and changes in IBV genomes in response to immune pressure are not well characterized. There are two lineages of IBV that have circulated in the human population since the 1980s, B-Victoria and B-Yamagata. It is hypothesized that early exposure to one influenza subtype leads to immunodominance. Subsequent seasonal vaccination or exposure to new subtypes may modify subsequent immune responses, which, in turn, results in selection of escape mutations in the viral genome. Here we show that while some mutations do occur in known epitopes suggesting antibody escape, many mutations occur in other parts of the HA protein. Analysis of mutations outside of the known epitopes revealed that these mutations occurred at the same amino acid position in viruses from each of the two IBV lineages. Interestingly, where the amino acid sequence differed between viruses from each lineage, reciprocal amino acid changes were observed. That is, the virus from the Yamagata lineage become more like the Victoria lineage virus and vice versa. Our results suggest that some IBV HA sequences are constrained to specific amino acid codons when viruses are cultured in the presence of antibodies. Some changes to the known antigenic regions may also be restricted in a lineage-dependent manner. Questions remain regarding the mechanisms underlying these results. The presence of amino acid residues that are constrained within the HA may provide a new target for universal vaccines for IBV.
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Jones, Jeremy C., Bindumadhav M. Marathe, Christian Lerner, Lukas Kreis, Rodolfo Gasser, Philippe Noriel Q. Pascua, Isabel Najera, and Elena A. Govorkova. "A Novel Endonuclease Inhibitor Exhibits Broad-Spectrum Anti-Influenza Virus ActivityIn Vitro." Antimicrobial Agents and Chemotherapy 60, no. 9 (July 5, 2016): 5504–14. http://dx.doi.org/10.1128/aac.00888-16.
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ABSTRACTAntiviral drugs are important in preventing and controlling influenza, particularly when vaccines are ineffective or unavailable. A single class of antiviral drugs, the neuraminidase inhibitors (NAIs), is recommended for treating influenza. The limited therapeutic options and the potential risk of antiviral resistance are driving the search for additional small-molecule inhibitors that act on influenza virus proteins. The acid polymerase (PA) of influenza viruses is a promising target for new antivirals because of its essential role in initiating virus transcription. Here, we characterized a novel compound, RO-7, identified as a putative PA endonuclease inhibitor. RO-7 was effective when added before the cessation of genome replication, reduced polymerase activity in cell-free systems, and decreased relative amounts of viral mRNA and genomic RNA during influenza virus infection. RO-7 specifically inhibited the ability of the PA endonuclease domain to cleave a nucleic acid substrate. RO-7 also inhibited influenza A viruses (seasonal and 2009 pandemic H1N1 and seasonal H3N2) and B viruses (Yamagata and Victoria lineages), zoonotic viruses (H5N1, H7N9, and H9N2), and NAI-resistant variants in plaque reduction, yield reduction, and cell viability assays in Madin-Darby canine kidney (MDCK) cells with nanomolar to submicromolar 50% effective concentrations (EC50s), low toxicity, and favorable selective indices. RO-7 also inhibited influenza virus replication in primary normal human bronchial epithelial cells. Overall, RO-7 exhibits broad-spectrum activity against influenza A and B viruses in multiplein vitroassays, supporting its further characterization and development as a potential antiviral agent for treating influenza.
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Pelton, Stephen I., Maarten Postma, Victoria Divino, Joaquin F. Mould-Quevedo, Ruthwik Anupindi, Mitchell DeKoven, and myron J. levin. "1341. Relative Vaccine Effectiveness Against Influenza-related Hospitalizations and Respiratory Events During the 2019/20 Influenza seAson in U.S. Children and Adults. A Real-World Evidence Comparison Between Quadrivalent Cell-based and Egg-based Influenza Vaccines." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S758. http://dx.doi.org/10.1093/ofid/ofab466.1533.
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Abstract Background Non-egg-based influenza vaccine manufacturing reduces egg adaptation and therefore has the potential to increase vaccine effectiveness. This study evaluated whether the cell-based quadrivalent influenza vaccine (QIVc) improved relative vaccine effectiveness (rVE) compared to standard-dose egg-based quadrivalent influenza vaccine (QIVe-SD) in the reduction of influenza-related and respiratory-related hospitalizations/emergency room (ER) visits among subjects 4-64 years old during the 2019/20 influenza season. Methods A retrospective analysis was conducted among subjects 4-64 years old vaccinated with QIVc or QIVe-SD using administrative claims data in the United States of America (U.S.) (IQVIA PharMetrics® Plus). Inverse probability of treatment weighting (IPTW) was used to adjust for baseline confounders. Post-IPTW, the number of events and rates (per 1,000 vaccinated subject-seasons) of influenza-related hospitalizations/ER visits, respiratory-related hospitalizations/ER visits and all-cause hospitalizations were assessed. Poisson regression was used to estimate adjusted rVE. To avoid any influenza outcome misclassification with COVID-19 infection, the study period ended March 7,2020. A sub-analysis for a high-risk subgroup was conducted. Urinary tract infection (UTI) hospitalization was assessed as a negative control endpoint. Results During the 2019/20 influenza season, 1,150,134 QIVc and 3,924,819 QIVe-SD recipients were identified post-IPTW. Overall adjusted analyses (4-64 years old) found that QIVc was associated with a significantly higher rVE compared to QIVe-SD against influenza-related hospitalizations/ER visits (5.3% [95% CI: 0.5%-9.9%]), all-cause hospitalizations (14.5% [95% CI: 13.1%-15.8%]) and any respiratory-related hospitalization/ER visit (8.2% [95% CI: 6.5%-9.8%]). A similar trend was seen for the high-risk subgroup; for instance, rVE for QIVc compared to QIVe-SD against influenza-related hospitalizations/ER visits was 10.5% [95% CI: 2.9%-17.4%]. No effect was identified for the negative control outcome. Conclusion QIVc was significantly more effective in preventing influenza-related and respiratory-related hospitalizations/ER visits, as well as all-cause hospitalizations, compared to QIVe-SD. Disclosures Stephen I. Pelton, MD, Seqirus (Consultant) Maarten Postma, Dr., Seqirus (Consultant) Victoria Divino, PhD, Seqirus (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus (Employee) Ruthwik Anupindi, PhD, Seqirus (Consultant) Mitchell DeKoven, PhD, Seqirus (Consultant) myron J. levin, MD, GSK group of companies (Employee, Research Grant or Support)
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Karras, Nicole, Wendy Sessions, Bruce R. Blazar, John E. Wagner, and Michael R. Verneris. "A Randomized Trial of One Vs. Two Doses of Influenza Vaccine Following Allogeneic Transplantation." Blood 120, no. 21 (November 16, 2012): 1896. http://dx.doi.org/10.1182/blood.v120.21.1896.1896.
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Abstract Abstract 1896 Following hematopoietic stem cell transplantation (HSCT) influenza infections can be potentially life threatening. Prior studies demonstrate that following HSCT, the influenza vaccine is relatively ineffective at inducing influenza specific immunity—especially early after transplant. Additionally, the effectiveness of the annual vaccine depends on recipient age, immune competence and antigenic potential of the three strains included. We hypothesized that a second vaccine dose, as is standard of care in vaccine naïve pediatric patients, might improve vaccine specific immune responses in patients following allogeneic HSCT. During the 2010 influenza season, we conducted a clinical trial where patients who were >60 days post HSCT were stratified by age and steroid use, and randomized to receive either 1 (n=33) or 2 (n=32) influenza vaccinations separated by one month. Blood samples were obtained pre-vaccination, 4 weeks and 8 weeks after the first vaccine. Vaccine specific B and T cell responses were assessed using hemagglutination inhibition (HAI) and IFN-g ELISPOT, respectively. Of the 65 patients, 73% (n=48) were >18 yrs old, 40% (n=26) received non-myeloablative conditioning and 35% (n=23) were umbilical cord blood (UCB) transplant recipients. HAI responses to the 2010/2011 vaccine components (H3N2, H1N1 and B/Victoria) were significantly greater for patients vaccinated >1 year post transplant (p<=0.005 for all 3 strains) compared to those vaccinated at earlier time points. Testing of T cell specific responses (IFN-g ELISPOT at week 8) showed 29/65 (45%) patients had IFN-g vaccine specific responses (defined as >5x increase in the number of spots over baseline). Recipients of 2 vaccines did not show a significant improvement in either HAI or in IFN-g ELISPOT responses. The HAI results were similar to the T cell specific responses in that patients >1 year after HSCT were more likely to develop positive responses compared to those vaccinated <1 yr (p=0.03). UCB recipients were less likely to have an influenza specific T cell response (p=<0.001). Flow cytometry was performed to determine whether the numbers of pre-vaccination naïve, effector memory or central memory T and or similar B cell populations were associated with responses. There was a positive correlation between the total number of CD19+ cells prior to vaccination and seroconversion (p=0.01) and an inverse correlation for IFN-g responses (p=0.05). No correlation with CD4+ subsets were found for either seroconversion or IFN-g positivity. In multivariate analysis for HAI responses, time from transplant to vaccination, and greater numbers of prevaccination CD19+ cells were significantly associated with responses (p<0.001 and p=0.01 respectively). Multivariate analysis for vaccine specific ELISPOT responses demonstrated significance for stem cell source (PB/BM > UCB, p=0.005) and CD19+ unswitched memory cells (p=0.008). Our study illustrates that time from transplantation was the strongest predictor of vaccine associated responses, and that vaccine specific T cell responses can be elicited prior to antibody responses. Furthermore, UCB recipients had significantly fewer IFN-g vaccine specific responses. Surprisingly steroid use did not negatively impact vaccine responses. In summary an additional influenza vaccine dose, separated by 1 month, did not increase vaccine responses. Disclosures: Blazar: Tarix Pharmaceuticals: Research Funding; Boehringer Ingelheim: Research Funding; Acetylon Pharmaceuticals, Inc.: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; University of Minnesota/University of Pennsylvania: Licensing Agreement, Licensing Agreement Other; Athelos-NeoStem, Inc.: Consultancy.