Journal articles: 'BEXERO VACCINE'

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Wallenfels, Jiří. "News on vaccines against meningococcal disease. Vaccine Bexsero." Hygiena 64, no. 2 (June 13, 2019): 85. http://dx.doi.org/10.21101/hygiena.b0034.

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Semchenko, Evgeny A., Aimee Tan, Ray Borrow, and Kate L. Seib. "The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria gonorrhoeae." Clinical Infectious Diseases 69, no. 7 (December 14, 2018): 1101–11. http://dx.doi.org/10.1093/cid/ciy1061.

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Abstract Background Neisseria gonorrhoeae and Neisseria meningitidis are closely-related bacteria that cause a significant global burden of disease. Control of gonorrhoea is becoming increasingly difficult, due to widespread antibiotic resistance. While vaccines are routinely used for N. meningitidis, no vaccine is available for N. gonorrhoeae. Recently, the outer membrane vesicle (OMV) meningococcal B vaccine, MeNZB, was reported to be associated with reduced rates of gonorrhoea following a mass vaccination campaign in New Zealand. To probe the basis for this protection, we assessed the cross-reactivity to N. gonorrhoeae of serum raised to the meningococcal vaccine Bexsero, which contains the MeNZB OMV component plus 3 recombinant antigens (Neisseria adhesin A, factor H binding protein [fHbp]-GNA2091, and Neisserial heparin binding antigen [NHBA]-GNA1030). Methods A bioinformatic analysis was performed to assess the similarity of MeNZB OMV and Bexsero antigens to gonococcal proteins. Rabbits were immunized with the OMV component or the 3 recombinant antigens of Bexsero, and Western blots and enzyme-linked immunosorbent assays were used to assess the generation of antibodies recognizing N. gonorrhoeae. Serum from humans immunized with Bexsero was investigated to assess the nature of the anti-gonococcal response. Results There is a high level of sequence identity between MeNZB OMV and Bexsero OMV antigens, and between the antigens and gonococcal proteins. NHBA is the only Bexsero recombinant antigen that is conserved and surfaced exposed in N. gonorrhoeae. Bexsero induces antibodies in humans that recognize gonococcal proteins. Conclusions The anti-gonococcal antibodies induced by MeNZB-like OMV proteins could explain the previously-seen decrease in gonorrhoea following MeNZB vaccination. The high level of human anti-gonococcal NHBA antibodies generated by Bexsero vaccination may provide additional cross-protection against gonorrhoea.

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Lakos, András, Péter Torzsa, and Tamás Ferenci. "Bexsero, egy új, meningococcus elleni vakcina." Orvosi Hetilap 157, no. 7 (February 2016): 242–46. http://dx.doi.org/10.1556/650.2016.30333.

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Meningococcus B is the most prevalent Neisseria meningitidis serogroup isolated in Hungary. Bexsero is one of the vaccines developed against it, which has been available in Hungary since the summer of 2014. The authors summarize the most important issues and open questions concerning the disease and the vaccine based on literature review. Based on immunological evidence, it is expected that Bexsero provides protection against this rare but very serious infection. However, the vaccine is extremely expensive, the clinical effectiveness has not yet been proven and it frequently causes fever, especially in infants where the vaccine is most needed. According to the opinion of the authors, the formulation of a Hungarian guideline concerning the application of Bexsero should be postponed until the accumulating international experience makes it possible to better judge the vaccine’s benefits, risks and cost-effectiveness. For patients with asplenia, complement defect or other immunological defect, or in case of markedly increased individual risk of contracting the disease, the vaccination is already justified. Orv. Hetil., 2016, 157(7), 242–246.

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Koroleva, I. S., and M. A. Koroleva. "World Experience in the Use Serogroup B Meningococcal Vaccines (literature review)." Epidemiology and Vaccinal Prevention 20, no. 6 (January 6, 2022): 100–107. http://dx.doi.org/10.31631/2073-3046-2021-20-6-100-107.

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Relevance. The success of vaccine prophylaxis of meningococcal infection depends on the composition and properties of vaccine preparations and the strict implementation of recommendations on vaccine prophylaxis tactics by the territorial epidemiological characteristics of meningococcal infection. Despite the high burden of B-meningococcal infection, especially among young children, the design of B-meningococcal vaccines has faced serious difficulties. Aim. The literature review presents the history of the development of B-meningococcal vaccines and provides characteristics of two immunologically effective and safe new generation B-meningococcal vaccine preparations. Conclusion. The licensing of the two new B-meningococcal vaccines presented in the review (Bexsero and Trumenba) was based on immunogenicity and safety. The inclusion of vaccines in national vaccination programs requires careful analysis, including analysis of the antigenic characteristics of circulating strains.

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Rodrigues, Charlene M. C., Hannah Chan, Caroline Vipond, Keith Jolley, Odile B. Harrison, Jun Wheeler, Gail Whiting, Ian M. Feavers, and Martin C. J. Maiden. "Typing complex meningococcal vaccines to understand diversity and population structure of key vaccine antigens." Wellcome Open Research 3 (November 29, 2018): 151. http://dx.doi.org/10.12688/wellcomeopenres.14859.1.

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Background:Protein-conjugate capsular polysaccharide vaccines can potentially control invasive meningococcal disease (IMD) caused by five (A, C, W, X, Y) of the six IMD-associated serogroups. Concerns raised by immunological similarity of the serogroup B capsule, to human neural cell carbohydrates, has meant that ‘serogroup B substitute’ vaccines target more variable subcapsular protein antigens. A successful approach using outer membrane vesicles (OMVs) as major vaccine components had limited strain coverage. In 4CMenB (Bexsero®), recombinant proteins have been added to ameliorate this problem. Methods:Here, scalable, portable, genomic techniques were used to investigate the Bexsero®OMV protein diversity in meningococcal populations. Shotgun proteomics identified 461 proteins in the OMV, defining a complex proteome. Amino acid sequences for the 24 proteins most likely to be involved in cross-protective immune responses were catalogued within thePubMLST.org/neisseriadatabase using a novel OMV peptide Typing (OMVT) scheme.Results:Among these proteins there was variation in the extent of diversity and association with meningococcal lineages, identified as clonal complexes (ccs), ranging from the most conserved peptides (FbpA, NEISp0578, and putative periplasmic protein, NEISp1063) to the most diverse (TbpA, NEISp1690). There were 1752 unique OMVTs identified amongst 2492/3506 isolates examined by whole-genome sequencing (WGS). These OMVTs were grouped into clusters (sharing ≥18 identical OMVT peptides), with 45.3% of isolates assigned to one of 27 OMVT clusters. OMVTs and OMVT clusters were strongly associated with cc, genogroup, and Bexsero®antigen variants, demonstrating that combinations of OMV proteins exist in discrete, non-overlapping combinations associated with genogroup and Bexsero®Antigen Sequence Type. This highly structured population of IMD-associated meningococci is consistent with strain structure models invoking host immune selection.Conclusions:The OMVT scheme facilitates region-specific WGS investigation of meningococcal diversity and is an open-access, portable tool with applications for vaccine development, especially in the choice of antigen combinations, assessment and implementation.

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Rodrigues, Charlene M. C., Hannah Chan, Caroline Vipond, Keith Jolley, Odile B. Harrison, Jun Wheeler, Gail Whiting, Ian M. Feavers, and Martin C. J. Maiden. "Typing complex meningococcal vaccines to understand diversity and population structure of key vaccine antigens." Wellcome Open Research 3 (March 19, 2019): 151. http://dx.doi.org/10.12688/wellcomeopenres.14859.2.

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Background:Protein-conjugate capsular polysaccharide vaccines can potentially control invasive meningococcal disease (IMD) caused by five (A, C, W, X, Y) of the six IMD-associated serogroups. Concerns raised by immunological similarity of the serogroup B capsule to human neural cell carbohydrates, meant that ‘serogroup B substitute’ vaccines target more variable subcapsular protein antigens. A successful approach using outer membrane vesicles (OMVs) as major vaccine components had limited strain coverage. In 4CMenB (Bexsero®), recombinant proteins have been added to ameliorate this problem. Methods: Scalable, portable, genomic techniques were used to investigate the Bexsero®OMV protein diversity in meningococcal populations. Shotgun proteomics identified 461 proteins in the OMV, defining a complex proteome. Amino acid sequences for the 24 proteins most likely to be involved in cross-protective immune responses were catalogued within thePubMLST.org/neisseriadatabase using a novel OMV peptide Typing (OMVT) scheme.Results:Among these proteins there was variation in the extent of diversity and association with meningococcal lineages, identified as clonal complexes (ccs), ranging from the most conserved peptides (FbpA, NEISp0578, and putative periplasmic protein, NEISp1063) to the most diverse (TbpA, NEISp1690). There were 1752 unique OMVTs identified amongst 2492/3506 isolates examined by whole-genome sequencing (WGS). These OMVTs were grouped into clusters (sharing ≥18 identical OMVT peptides), with 45.3% of isolates assigned to one of 27 OMVT clusters. OMVTs and OMVT clusters were strongly associated with cc, genogroup, and Bexsero®antigen variants, demonstrating that combinations of OMV proteins exist in discrete, non-overlapping combinations associated with genogroup and Bexsero®Antigen Sequence Type. This highly structured population of IMD-associated meningococci is consistent with strain structure models invoking host immune and/or metabolic selection.Conclusions:The OMVT scheme facilitates region-specific WGS investigation of meningococcal diversity and is an open-access, portable tool with applications for vaccine development, especially in the choice of antigen combinations, assessment and implementation.

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Rodrigues, Charlene M. C., Keith A. Jolley, Andrew Smith, J. Claire Cameron, Ian M. Feavers, and Martin C. J. Maiden. "Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) Index: a Rapid and Accessible Tool That Exploits Genomic Data in Public Health and Clinical Microbiology Applications." Journal of Clinical Microbiology 59, no. 1 (October 14, 2020): e02161-20. http://dx.doi.org/10.1128/jcm.02161-20.

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ABSTRACTAs microbial genomics makes increasingly important contributions to clinical and public health microbiology, the interpretation of whole-genome sequence data by nonspecialists becomes essential. In the absence of capsule-based vaccines, two protein-based vaccines have been used for the prevention of invasive serogroup B meningococcal disease (IMD) since their licensure in 2013 and 2014. These vaccines have different components and different levels of coverage of meningococcal variants. Hence, decisions regarding which vaccine to use in managing serogroup B IMD outbreaks require information about the index case isolate, including (i) the presence of particular vaccine antigen variants, (ii) the expression of vaccine antigens, and (iii) the likely susceptibility of its antigen variants to antibody-dependent bactericidal killing. To obtain this information requires a multitude of laboratory assays, impractical in real-time clinical settings, where the information is most urgently needed. To facilitate assessment for public health and clinical purposes, we synthesized genomic and experimental data from published sources to develop and implement the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) Index, which is publicly available on PubMLST (https://pubmlst.org). Using whole-genome sequences or individual gene sequences obtained from IMD isolates or clinical specimens, the MenDeVAR Index provides rapid evidence-based information on the presence and possible immunological cross-reactivity of different meningococcal vaccine antigen variants. The MenDeVAR Index enables practitioners who are not genomics specialists to assess the likely reactivity of vaccines for individual cases, outbreak management, or the assessment of public health vaccine programs. The MenDeVAR Index has been developed in consultation with, but independently of, both the 4CMenB (Bexsero; GSK) and rLP2086 (Trumenba; Pfizer, Inc.) vaccine manufacturers.

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Maritan, Martina, Roberta Cozzi, Paola Lo Surdo, Daniele Veggi, Matthew James Bottomley, and Enrico Malito. "Crystal structures of human Fabs targeting the Bexsero meningococcal vaccine antigen NHBA." Acta Crystallographica Section F Structural Biology Communications 73, no. 6 (May 11, 2017): 305–14. http://dx.doi.org/10.1107/s2053230x17006021.

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Neisserial heparin-binding antigen (NHBA) is a surface-exposed lipoprotein fromNeisseria meningitidisand is a component of the meningococcus B vaccine Bexsero. As part of a study to characterize the three-dimensional structure of NHBA and the molecular basis of the human immune response to Bexsero, the crystal structures of two fragment antigen-binding domains (Fabs) isolated from human monoclonal antibodies targeting NHBA were determined. Through a high-resolution analysis of the organization and the amino-acid composition of the CDRs, these structures provide broad insights into the NHBA epitopes recognized by the human immune system. As expected, these Fabs also show remarkable structural conservation, as shown by a structural comparison of 15 structures of apo Fab 10C3 which were obtained from crystals grown in different crystallization conditions and were solved while searching for a complex with a bound NHBA fragment or epitope peptide. This study also provides indirect evidence for the intrinsically disordered nature of two N-terminal regions of NHBA.

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Peterson, James, Carmen Deseda, Katie Julien, Betzana Zambrano, Germán Áñez, Sue Jiayuan, Judy Pan, et al. "03. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster Dose in Adults and Adolescents Vaccinated Against Meningococcal Disease 3 - 6 Years Earlier." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S125. http://dx.doi.org/10.1093/ofid/ofab466.206.

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Abstract Background Booster doses of meningococcal conjugate vaccines may induce long-term protection against invasive meningococcal disease. MenACYW-TT [MenQuadfi®] is a quadrivalent meningococcal conjugate vaccine, licensed for use in ages 2 years and older in USA. The vaccine is also licensed in ages 12 months and older in EU and other countries. Methods A phase IIIb study (NCT04084769) was conducted to evaluate the persistence of immune response in adults and adolescents primed 3-6 years earlier with either MenACYW-TT or MCV4-CRM (Menveo®) and, safety and immunogenicity of MenACYW-TT when administered as a booster dose with or without concomitant administration with MenB vaccines (Bexsero® and Trumenba®). Serum bactericidal assays with human complement (hSBA) and baby rabbit complement (rSBA) were used to measure antibodies against vaccine serogroups at baseline (Day 0 [D0]), D06 (in a subset) and 30 days post-vaccination (D30). Safety data were collected up to 6 months post-vaccination. Results At D0, the GMTs were higher in subjects primed with MenACYW-TT vs MCV4-CRM for serogroups C, Y and W, and were comparable for serogroup A. At D0, all hSBA GMTs were higher than those observed pre-priming dose, suggesting persistence of immunity. Sufficiency of hSBA seroresponse ( >75%) was demonstrated following administration of MenACYW-TT booster dose regardless of the priming vaccine administered 3-6 years earlier. Vaccine seroresponse in a subset of participants at D06 ranged from 77.8% (95%CI 62.9%; 88.8%) for serogroup A to 97.8% (88.5%; 99.9%) for serogroup W suggesting a quick onset of immune response post-booster. Post-vaccination (D30) hSBA GMTs were comparable for serogroups A, Y and W regardless of the nature of the priming vaccine and were higher for serogroup C in subjects primed with MenACYW-TT vaccine. The MenACYW-TT booster dose was well-tolerated and had similar safety profiles regardless of the priming vaccine. The safety profiles were comparable regardless of the MenB vaccine co-administered with MenACYW-TT vaccine. Conclusion MenACYW-TT used as priming vaccine was able to demonstrate persistence of immune response 3-6 years later. MenACYW-TT elicits robust booster responses in adults and adolescents primed with MenACYW-TT or MCV4-CRM Disclosures Betzana Zambrano, MD, Sanofi Pasteur (Employee) Germán Áñez, MD, Sanofi Pasteur (Other Financial or Material Support, Former employee) Sue Jiayuan, MSc, Sanofi Pasteur (Independent Contractor) Judy Pan, PhD, Sanofi Pasteur (Employee) Habiba Arroum, MD, Sanofi Pasteur (Employee) Kucku Varghese, PhD, Sanofi Pasteur (Employee) Emilia Jordanov, MD, Sanofi Pasteur (Employee, Shareholder) Mandeep S. Dhingra, MD, Sanofi Pasteur (Employee, Shareholder)

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Carr, Jeremy, Emma Plested, Parvinder Aley, Susana Camara, Kimberly Davis, Jenny M. MacLennan, Steve Gray, et al. "‘Be on the TEAM’ Study (Teenagers Against Meningitis): protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents." BMJ Open 10, no. 10 (October 2020): e037358. http://dx.doi.org/10.1136/bmjopen-2020-037358.

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IntroductionCapsular group B Neisseria meningitidis (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B ‘substitute’ vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel ‘MenB’ protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal Neisseria spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease.Methods and analysisThe ‘Be on the TEAM’ (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16–19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other Neisseria spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development.Ethics and disseminationThis study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools.Trial registration numbersISRCTN75858406; Pre-results, EudraCT 2017-004609-42.

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Gönüllü, Erdem, Burcu Topçu, Naci Öner, Ahmet Soysal, and Metin Karaböcüoğlu. "Fever-Associated Supraventricular Tachycardia after 4CMenB Vaccination in an Infant." Case Reports in Pediatrics 2019 (September 22, 2019): 1–3. http://dx.doi.org/10.1155/2019/4591964.

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Meningococcal serogroup B vaccine 4CMenB (Bexsero) is a new four-component protein vaccine developed to prevent Neisseria meningitidis serogroup B infections. Case. We report a girl with fever and supraventricular tachycardia (SVT) 6–8 hours after the second dose of 4CMenB. SVT was unresponsive to the first dose of adenosine but terminated after the fourth dose of adenosine. During three months of follow-up, she was free of further SVT attacks. Conclusion. This is the first report of ECG-proven SVT after 4CMenB vaccination. Even if fever is coexistent, SVT should be considered after persistent tachycardia and 4CMenB vaccination.

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Flaxman, Amy, and Katie Ewer. "Methods for Measuring T-Cell Memory to Vaccination: From Mouse to Man." Vaccines 6, no. 3 (July 21, 2018): 43. http://dx.doi.org/10.3390/vaccines6030043.

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The development of effective vaccines continues to be a key goal for public health bodies, governments, funding bodies and pharmaceutical companies. With new vaccines such as Shingrix targeting Shingles and Bexsero for Meningitis B, licensed in recent years, today’s population can be protected from more infectious diseases than ever before. Despite this, we are yet to license vaccines for some of the deadliest endemic diseases affecting children, such as malaria. In addition, the threat of epidemics caused by emerging pathogens is very real as exemplified by the 2014–2016 Ebola outbreak. Most licensed vaccines provide efficacy through humoral immunity and correlates of protection often quantify neutralising antibody titre. The role of T-cells in vaccine efficacy is less well understood and more complex to quantify. Defining T-cell responses which afford protection also remains a challenge, although more sophisticated assays for assessing cell-mediated immunity with the potential for higher throughput and scalability are now available and warrant review. Here we discuss the benefits of multiparameter cytokine analysis and omics approaches compared with flow cytometric and ELISpot assays. We also review technical challenges unique to clinical trial studies, including assay validation across laboratories and availability of sample type. Measuring T-cell immunogenicity alongside humoral responses provides information on the breadth of immune responses induced by vaccination. Accurately enumerating and phenotyping T-cell immunogenicity to vaccination is key for the determination of immune correlates of protection. However, identifying such T-cell parameters remains challenging without a clear understanding of the immunological mechanisms by which a T-cell-mediated response induces protection.

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Dubé, Eve, Dominique Gagnon, Denis Hamel, Sylvie Belley, Hélène Gagné, Nicole Boulianne, Monique Landry, and Julie A. Bettinger. "Parents’ and Adolescents’ Willingness to be Vaccinated Against Serogroup B Meningococcal Disease during a Mass Vaccination in Saguenay–Lac-St-Jean (Quebec)." Canadian Journal of Infectious Diseases and Medical Microbiology 26, no. 3 (2015): 163–67. http://dx.doi.org/10.1155/2015/732464.

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A mass vaccination campaign with the 4CMenB vaccine (Bexsero®; Novartis Pharmaceutical Canada Inc) was launched in a serogroup B endemic area in Quebec. A telephone survey was conducted to assess parental and adolescent opinions about the acceptability of the vaccine. Intent to receive the vaccine or vaccine receipt was reported by the majority of parents (93%) and adolescents (75%). Meningitis was perceived as being a dangerous disease by the majority of parents and adolescents. The majority of respondents also considered the 4CMenB vaccine to be safe and effective. The main reason for positive vaccination intention or behaviour was self-protection, while a negative attitude toward vaccination in general was the main reason mentioned by parents who did not intend to have their child vaccinated. Adolescents mainly reported lack of interest, time or information, and low perceived susceptibility and disease severity as the main reasons for not intending to be vaccinated or not being vaccinated.

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HUELS, J., K. M. CLEMENTS, L. J. McGARRY, G. J. HILL, J. WASSIL, and S. KESSABI. "Modelled evaluation of multi-component meningococcal vaccine (Bexsero®) for the prevention of invasive meningococcal disease in infants and adolescents in the UK." Epidemiology and Infection 142, no. 9 (November 28, 2013): 2000–2012. http://dx.doi.org/10.1017/s095026881300294x.

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SUMMARYNeisseria meningitidis is the main cause of bacterial meningitis and sepsis in the UK, and can potentially be lethal or cause long-term sequelae. Bexsero® (4CMenB) is a new multi-component vaccine approved by the European Commission for use in individuals aged ⩾2 months. A theoretical transmission model was constructed to assess the long-term effectiveness of Bexsero compared to standard care. The model was populated with UK-specific demographic data and calibrated to ensure that the transmission dynamics of meningococcal disease in the UK were adequately simulated. The model showed the best strategy to be a routine vaccination programme at ages 2, 3, 4, 12 months and 14 years combined with a 5-year catch-up programme in toddlers aged 12–24 months and adolescents aged 15–18 years. This would lead to a 94% reduction in meningococcal cases or 150 000 cases and 15 000 deaths over a 100-year time-frame.

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Hong, Eva, Aude Terrade, and Muhamed-Kheir Taha. "Immunogenicity and safety among laboratory workers vaccinated with Bexsero® vaccine." Human Vaccines & Immunotherapeutics 13, no. 3 (November 3, 2016): 645–48. http://dx.doi.org/10.1080/21645515.2016.1241358.

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Perez-Vilar, Silvia, Graça M. Dores, Paige L. Marquez, Carmen S. Ng, Maria V. Cano, Anuja Rastogi, Lucia Lee, John R. Su, and Jonathan Duffy. "Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015–2018." Vaccine 40, no. 2 (January 2022): 247–54. http://dx.doi.org/10.1016/j.vaccine.2021.11.071.

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Sacoun, Esther. "Demande d’AMM pour Bexsero®, un vaccin contre le méningocoque B." Option/Bio 22, no. 452 (April 2011): 7. http://dx.doi.org/10.1016/s0992-5945(11)70722-x.

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Roeth, Alexander, Ferras Alashkar, Doerte Herich-Terhuerne, Johannes Elias, Ulrich Vogel, and Ulrich Duehrsen. "Serologic Response to Meningococcal Vaccination in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) for the Chronic Treatment with the Terminal Complement Inhibitor Eculizumab." Blood 124, no. 21 (December 6, 2014): 4380. http://dx.doi.org/10.1182/blood.v124.21.4380.4380.

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Abstract BACKGROUND: Eculizumab is indicated for the therapy of patients with symptomatic paroxysmal nocturnal hemoglobinuria (PNH). Due to inhibition of terminal complement cascade, patients on eculizumab are susceptible to N. meningitids infections (0.48 cases per 100-patient years). The two mainstays to reduce the risk of infection are vaccination at least two weeks prior to treatment and antibiotic prophylaxis. PATIENTS/METHODS: In this retrospective study serologic response was analyzed after vaccination with a meningococcal vaccine in PNH patients (n=32) by measuring serum bactericidal antibody titers with external rabbit complement (rSBA) against meningococci serogroups A, C, W and Y. 78.1% of the patients (25/32) received a tetravalent conjugate vaccine, while 6.3% (2/32) received an unconjugated polysaccharide vaccine. In 9.4% (n=3) the type of vaccine administrated was not available. Serologic response was defined by an rSBA titer ≥1:8. In 23 patients the corresponding rSBA titers were available. 39.1% (9/23) had been vaccinated more than once due to chronic eculizumab treatment. RESULTS: Overall serologic responses independent of the time of observation for the meningococcal serogroups were: A: 78.3%, C: 86.9%, W: 47.8%, Y: 69.6%. rSBA titers varied significantly for the different time points [≤2 months (n=1): A: 100%, C: 100%, W: 100%, Y: 100%; ≤4-<6 months (n=4): A: 75%, C: 100%, W: 75%, Y: 75%; ≥6-<12 months (n=5): A: 60%, C: 40%, W: 0%, Y: 40%; ≥ 12-36 months (n=13): A: 84.6%, C: 100%, W: 53.8%, Y: 76.9%]. In 5 patients (15.6%) rSBA titers against 3 serogroups were <1:8, while 5 other patients (15.6%) had rSBA titers <1:8 against 2 serogroups at the same time. Serologic response after vaccination with an unconjugated vaccine even for the third time (n=1) prior to observation due to chronic therapy was identical to patients who had been vaccinated only once, supporting a non-immunological memory post vaccination with an unconjugated vaccine. No meningococcal infections have been observed in the analyzed cohort of eculizumab treated PNH patients so far. SUMMARY/CONCLUSIONS: Efficiency of meningococcal vaccines for the different serotypes varies significantly and serological response analyses are very useful. Revaccination with the tetravalent conjugate vaccine (Menveo®) every 3 years is recommended or should be based on the individual response. However, physicians and patients must be vigilant for meningococcal infections at all times. Furthermore, stand-by therapy with ciprofloxacin 750 mg p.o. in case of signs of meningococcal infection and immediate medical evaluation and treatment is recommended. The availability of a novel vaccine covering the B-strain (Bexsero®) may further reduce the risk of an infection. Disclosures Roeth: Alexion: Consultancy, Honoraria, Research Funding. Duehrsen:Alexion: Honoraria.

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Haese, Ethan C., Van C. Thai, and Charlene M. Kahler. "Vaccine Candidates for the Control and Prevention of the Sexually Transmitted Disease Gonorrhea." Vaccines 9, no. 7 (July 20, 2021): 804. http://dx.doi.org/10.3390/vaccines9070804.

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The World Health Organization (WHO) has placed N. gonorrhoeae on the global priority list of antimicrobial resistant pathogens and is urgently seeking the development of new intervention strategies. N. gonorrhoeae causes 86.9 million cases globally per annum. The effects of gonococcal disease are seen predominantly in women and children and especially in the Australian Indigenous community. While economic modelling suggests that this infection alone may directly cost the USA health care system USD 11.0–20.6 billion, indirect costs associated with adverse disease and pregnancy outcomes, disease prevention, and productivity loss, mean that the overall effect of the disease is far greater still. In this review, we summate the current progress towards the development of a gonorrhea vaccine and describe the clinical trials being undertaken in Australia to assess the efficacy of the current formulation of Bexsero® in controlling disease.

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Coyne-Beasley, Tamera, Joseph Bocchini, Alejandro Cane, Cindy Burman, Maria J. Tort, and Jessica Presa. "01. Serum Bactericidal Activity Against Circulating and Reference Strains of Meningococcal Serogroup B in the United States: A Review of Meningococcal Serogroup B (MenB) Vaccines in Adolescents and Young Adults." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S124—S125. http://dx.doi.org/10.1093/ofid/ofab466.204.

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Abstract Background US adolescents and young adults are at particular risk of invasive meningococcal disease (IMD). In 2018, menincococcal serogroup B was responsible for 36% of IMD cases in the US overall and for 66% of cases in adolescents and young adults. This age group is at high risk of IMD during outbreaks, which result in significant response-related costs. MenB vaccine efficacy against IMD relies on its ability to provide broad protection against diverse disease-causing strains. MenB-FHbp (Trumenba) and MenB-4C (Bexsero) are MenB vaccines licensed in the US as 2-dose series with an interval of 6 mo or 1 mo, respectively, recommended in healthy adolescents and young adults. We review available data on vaccine coverage of serogroup B strains. Methods A literature review identified relevant information from peer-reviewed publications, congress presentations, and ClinicalTrials.gov. Previously presented but unpublished data from phase 2/3 studies were included. Results After 2 MenB-FHbp doses, percentages of adolescents and young adults achieving serum bactericidal activity assay using human complement (hSBA) titers ≥1:8 were 79%–99% for 4 heterologous representative test strains and 71%–97% for 10 additional strains, confirming cross-protection against a diverse strain panel (Figure 1; unpublished data). These 14 heterologous strains collectively represent ~80% of disease-causing strains in the US and Europe. In a published study with limited sample size, 44%–78% of subjects had hSBA titers ≥1:8 against strains from 4 US college outbreaks after 2 MenB-FHbp doses. After 2 MenB-4C doses, percentages of 10–25-year-olds achieving hSBA titers ≥1:5 against 3 reference strains homologous to the vaccine antigen were 82%–93% (published data); 15%–100% of adolescents achieved hSBA titers ≥1:4 against a panel of 14 strains (unpublished data). Of college students who received 2 MenB-4C doses, 53%–93% achieved hSBA titers ≥1:4 against 5 US outbreak strains (4/5 strains had antigenic similarity to MenB-4C; published data). Conclusion MenB-FHbp and MenB-4C protect against various serogroup B strains. As for the breadth of coverage provided by these vaccines, available data show that MenB-FHbp elicits robust immune responses to a wide variety of disease-causing strains prevalent in the US (Figure 2). Disclosures Tamera Coyne-Beasley, MD, MPH, Pfizer Inc and GlaxoSmithKline (Advisor or Review Panel member) Joseph Bocchini, MD, Pfizer Inc and Dynavax (Advisor or Review Panel member) Alejandro Cane, M.D., Pfizer Inc (Employee, Shareholder) Cindy Burman, PharmD, Pfizer Inc (Employee, Shareholder) Maria J. Tort, PhD, Pfizer Inc (Employee, Shareholder) Jessica Presa, MD, Pfizer Inc (Employee, Shareholder)

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Meier, Emily Riehm, Leticia Brown, Kisha Hampton, Ellen Bloom, DeAuntae Lawson, and Sarah A. Hall. "A Novel Sickle Cell Outreach Program Improves Access to TCD Screening, Vaccines and Hydroxyurea in a Medically Underserved Area." Blood 134, Supplement_1 (November 13, 2019): 4696. http://dx.doi.org/10.1182/blood-2019-130209.

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Background: The Sickle Care Coordination, OutReach, Education Program (SCORE) was created in 2017 to improve access to hematology care and care coordination services for children with sickle cell disease (SCD) in an urban community in Lake County, Indiana. Although Lake County has the second highest prevalence of SCD in Indiana, it lacks a pediatric hematologist, and the closest pediatric hematology practice is 65 miles away. Newborn screening data from 2009-2017 showed that only 25% of children in this underserved area received Transcranial Doppler (TCD) and only 25% received the 23 valent pneumococcal vaccine, compared with 70% for both in other regions of Indiana. The goal of the SCORE clinic is to increase TCD screening and vaccination rates as well as increase the number of children who are prescribed hydroxyurea (HU) at maximum tolerated dosing (MTD). Methods: Quarterly SCORE outreach clinics were established in Lake County, Indiana in August 2017, which is 145 miles Northwest of our center. A multi-disciplinary team (social worker, sickle cell educators, nursing staff) accompanies the pediatric hematologist and physician assistant to clinic. Vaccines are administered in SCORE clinic and laboratory tests are drawn on site. Same day TCD screening was established in May 2018. The state's electronic vaccine record was queried to determine which SCD-specific vaccines the children needed prior to each clinic. Education about SCD, HU, and needed screening tests like TCD was provided by members of the multi-disciplinary team. Results: One hundred thirty-one visits have been made to the 10 SCORE outreach clinics that have been held since August 2017. Forty children have received hematology care in the SCORE clinic; 35 (87.5%) children have had at least 2 visits. Twenty-two children were eligible for HU; sixteen (72.7%) were already taking HU at the time of their first visit to SCORE outreach clinic (mean dose prior to first SCORE visit: 18.6 + 5.9 mg/kg/day). Mean HU dose increased significantly after being followed by the SCORE clinic team (26.5 mg/kg/day, p=0.00002). The remaining 6 children initiated HU after receiving care in the SCORE outreach clinic. Nineteen children were eligible for TCD screening since their first SCORE clinic visit, and fourteen (73.7%) children completed the screening. One hundred twenty-one vaccines have been given in clinic to date: 100% of children who were eligible for the 23 valent pneumococcal, hepatitis A and B vaccines have received them. Seasonal influenza vaccine was given to 76.9% of eligible children. Forty-six of the 54 (85.2%) Menveo doses that were due were given, and 80% of Bexsero doses that were due were given. Conclusion: The SCORE program has increased access to pediatric hematology care for children with SCD in an urban, underserved community in Indiana. In the first 2 years of the program, TCD screening rates and pneumococcal vaccination rates have increased to the level seen in other regions of the state. Children who received care in the SCORE outreach clinic had a significant increase in their HU dosing. Outreach clinics can increase access to specialty care in underserved areas. Disclosures Meier: CVS Caremark: Consultancy. OffLabel Disclosure: Hydroxyurea prescription in children less than 2 years of age.

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Tani, Chiara, Maria Stella, Danilo Donnarumma, Massimiliano Biagini, Pierino Parente, Alessandro Vadi, Claudia Magagnoli, Paolo Costantino, Fabio Rigat, and Nathalie Norais. "Quantification by LC–MSE of outer membrane vesicle proteins of the Bexsero® vaccine." Vaccine 32, no. 11 (March 2014): 1273–79. http://dx.doi.org/10.1016/j.vaccine.2014.01.011.

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Leduc, Isabelle, Kristie L. Connolly, Afrin Begum, Knashka Underwood, Stephen Darnell, William M. Shafer, Jacqueline T. Balthazar, et al. "The serogroup B meningococcal outer membrane vesicle-based vaccine 4CMenB induces cross-species protection against Neisseria gonorrhoeae." PLOS Pathogens 16, no. 12 (December 8, 2020): e1008602. http://dx.doi.org/10.1371/journal.ppat.1008602.

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There is a pressing need for a gonorrhea vaccine due to the high disease burden associated with gonococcal infections globally and the rapid evolution of antibiotic resistance in Neisseria gonorrhoeae (Ng). Current gonorrhea vaccine research is in the stages of antigen discovery and the identification of protective immune responses, and no vaccine has been tested in clinical trials in over 30 years. Recently, however, it was reported in a retrospective case-control study that vaccination of humans with a serogroup B Neisseria meningitidis (Nm) outer membrane vesicle (OMV) vaccine (MeNZB) was associated with reduced rates of gonorrhea. Here we directly tested the hypothesis that Nm OMVs induce cross-protection against gonorrhea in a well-characterized female mouse model of Ng genital tract infection. We found that immunization with the licensed Nm OMV-based vaccine 4CMenB (Bexsero) significantly accelerated clearance and reduced the Ng bacterial burden compared to administration of alum or PBS. Serum IgG and vaginal IgA and IgG that cross-reacted with Ng OMVs were induced by 4CMenB vaccination by either the subcutaneous or intraperitoneal routes. Antibodies from vaccinated mice recognized several Ng surface proteins, including PilQ, BamA, MtrE, NHBA (known to be recognized by humans), PorB, and Opa. Immune sera from both mice and humans recognized Ng PilQ and several proteins of similar apparent molecular weight, but MtrE was only recognized by mouse serum. Pooled sera from 4CMenB-immunized mice showed a 4-fold increase in serum bactericidal50 titers against the challenge strain; in contrast, no significant difference in bactericidal activity was detected when sera from 4CMenB-immunized and unimmunized subjects were compared. Our findings directly support epidemiological evidence that Nm OMVs confer cross-species protection against gonorrhea, and implicate several Ng surface antigens as potentially protective targets. Additionally, this study further defines the usefulness of murine infection model as a relevant experimental system for gonorrhea vaccine development.

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Abad, R., A. Biolchi, M. Moschioni, M. M. Giuliani, M. Pizza, and J. A. Vázquez. "A Large Portion of Meningococcal Antigen Typing System-Negative Meningococcal Strains from Spain Is Killed by Sera from Adolescents and Infants Immunized with 4CMenB." Clinical and Vaccine Immunology 22, no. 4 (January 28, 2015): 357–60. http://dx.doi.org/10.1128/cvi.00669-14.

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ABSTRACTA new vaccine (the 4CMenB 4-component protein vaccine [Bexsero], which includes PorA, factor H-binding protein [fHbp], neisserial heparin-binding antigen [NHBA], andNeisseriaadhesin A [NadA]) against serogroup B meningococci has recently been approved for use in people older than age 2 months in Europe, Australia, and Canada. Preapproval clinical efficacy studies are not feasible for invasive meningococcal disease because its incidence is low/very low, and the serum bactericidal antibody (SBA) titer (or the human SBA [hSBA] titer when human complement is used in the assay) has been used as a surrogate marker of protection. However, the hSBA assay cannot be used on a large scale, and therefore, a meningococcal antigen typing system (MATS) was developed. MATS combines conventional PorA genotyping with an enzyme-linked immunosorbent assay (ELISA) that quantifies both the expression and the cross-reactivity of antigenic variants. The assay has been used to evaluate the potential of the 4CMenB meningococcal group B vaccine to cover group B strains in several countries. Some recent data suggest that MATS is a conservative predictor of strain coverage. We used pooled sera from adolescents and infants to test by the hSBA assay 10 meningococcal group B strains isolated in Spain that were negative for the 3 antigens (n= 9) or that had very low levels of the 3 antigens (n= 1) by MATS. We found that all strains were killed by sera from adolescents and that 5 of the 10 strains were also killed, although at a low titer, by sera from infants. Our data confirm that MATS underestimates vaccine coverage.

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Whiting, Gail, Caroline Vipond, Alessandra Facchetti, Hannah Chan, and Jun X. Wheeler. "Measurement of surface protein antigens, PorA and PorB, in Bexsero vaccine using quantitative mass spectrometry." Vaccine 38, no. 6 (February 2020): 1431–35. http://dx.doi.org/10.1016/j.vaccine.2019.11.082.

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Parent du Châtelet, I., D. Lévy-Bruhl, and M. K. Taha. "N-02: Critères d’alerte et d’intervention vaccinale avec le vaccin Bexsero® en situation de cas groupés d’infection invasive à méningocoque B." Médecine et Maladies Infectieuses 44, no. 6 (June 2014): 74. http://dx.doi.org/10.1016/s0399-077x(14)70267-7.

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Bertoldi, Isabella, Agnese Faleri, Barbara Galli, Paola Lo Surdo, Alessia Liguori, Nathalie Norais, Laura Santini, Vega Masignani, Mariagrazia Pizza, and Marzia Monica Giuliani. "Exploiting chimeric human antibodies to characterize a protective epitope ofNeisseriaadhesin A, one of the Bexsero vaccine components." FASEB Journal 30, no. 1 (August 24, 2015): 93–101. http://dx.doi.org/10.1096/fj.15-273813.

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Whelan, Jane, Helen Marshall, and Thomas R. Sullivan. "Intracluster correlation coefficients in a large cluster randomized vaccine trial in schools: Transmission and impact of shared characteristics." PLOS ONE 16, no. 10 (October 14, 2021): e0254330. http://dx.doi.org/10.1371/journal.pone.0254330.

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Cluster randomized trials (cRCT) to assess vaccine effectiveness incorporate indirect effects of vaccination, helping to inform vaccination policy. To calculate the sample size for a cRCT, an estimate of the intracluster correlation coefficient (ICC) is required. For infectious diseases, shared characteristics and social mixing behaviours may increase susceptibility and exposure, promote transmission and be a source of clustering. We present ICCs from a school-based cRCT assessing the effectiveness of a meningococcal B vaccine (Bexsero, GlaxoSmithKline) on reducing oropharyngeal carriage of Neisseria meningitidis (Nm) in 34,489 adolescents from 237 schools in South Australia in 2017/2018. We also explore the contribution of shared behaviours and characteristics to these ICCs. The ICC for carriage of disease-causing Nm genogroups (primary outcome) pre-vaccination was 0.004 (95% CI: 0.002, 0.007) and for all Nm was 0.007 (95%CI: 0.004, 0.011). Adjustment for social behaviours and personal characteristics reduced the ICC for carriage of disease-causing and all Nm genogroups by 25% (to 0.003) and 43% (to 0.004), respectively. ICCs are also reported for risk factors here, which may be outcomes in future research. Higher ICCs were observed for susceptibility and/or exposure variables related to Nm carriage (having a cold, spending ≥1 night out socializing or kissing ≥1 person in the previous week). In metropolitan areas, nights out socializing was a highly correlated behaviour. By contrast, smoking was a highly correlated behaviour in rural areas. A practical example to inform future cRCT sample size estimates is provided.

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Whelan, Jane, Helen Marshall, and Thomas R. Sullivan. "Intracluster correlation coefficients in a large cluster randomized vaccine trial in schools: Transmission and impact of shared characteristics." PLOS ONE 16, no. 10 (October 14, 2021): e0254330. http://dx.doi.org/10.1371/journal.pone.0254330.

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Cluster randomized trials (cRCT) to assess vaccine effectiveness incorporate indirect effects of vaccination, helping to inform vaccination policy. To calculate the sample size for a cRCT, an estimate of the intracluster correlation coefficient (ICC) is required. For infectious diseases, shared characteristics and social mixing behaviours may increase susceptibility and exposure, promote transmission and be a source of clustering. We present ICCs from a school-based cRCT assessing the effectiveness of a meningococcal B vaccine (Bexsero, GlaxoSmithKline) on reducing oropharyngeal carriage of Neisseria meningitidis (Nm) in 34,489 adolescents from 237 schools in South Australia in 2017/2018. We also explore the contribution of shared behaviours and characteristics to these ICCs. The ICC for carriage of disease-causing Nm genogroups (primary outcome) pre-vaccination was 0.004 (95% CI: 0.002, 0.007) and for all Nm was 0.007 (95%CI: 0.004, 0.011). Adjustment for social behaviours and personal characteristics reduced the ICC for carriage of disease-causing and all Nm genogroups by 25% (to 0.003) and 43% (to 0.004), respectively. ICCs are also reported for risk factors here, which may be outcomes in future research. Higher ICCs were observed for susceptibility and/or exposure variables related to Nm carriage (having a cold, spending ≥1 night out socializing or kissing ≥1 person in the previous week). In metropolitan areas, nights out socializing was a highly correlated behaviour. By contrast, smoking was a highly correlated behaviour in rural areas. A practical example to inform future cRCT sample size estimates is provided.

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Säll, Olof, Emma Olofsson, and Susanne Jacobsson. "High genomic-based predicted strain coverage among invasive meningococcal isolates when combining Bexsero and Trumenba vaccines." Vaccine 38, no. 28 (June 2020): 4374–78. http://dx.doi.org/10.1016/j.vaccine.2020.04.074.

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Hall, Gillian C., Ian Douglas, Paul T. Heath, Prab Prabhakar, Dominique Rosillon, Javeed Khan, and Victoria Abbing-Karahagopian. "Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero) vaccination within the routine UK immunisation program." Vaccine 39, no. 24 (June 2021): 3296–303. http://dx.doi.org/10.1016/j.vaccine.2021.02.065.

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Tirani, Marcello, Michela Meregaglia, and Alessia Melegaro. "Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme." PLOS ONE 10, no. 4 (April 13, 2015): e0123383. http://dx.doi.org/10.1371/journal.pone.0123383.

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Studholme, Lucy, Janet Sutherland, Trusha Desai, Jason Hockley, Rory Care, Ida Karin Nordgren, and Caroline Vipond. "Evaluation of the monocyte activation test for the safety testing of meningococcal B vaccine Bexsero: A collaborative study." Vaccine 37, no. 29 (June 2019): 3761–69. http://dx.doi.org/10.1016/j.vaccine.2018.05.073.

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Moura Silveira, Marcelle, Alan J. A. McBride, and Caroline L. Trotter. "Health impact and cost-effectiveness of introducing the vaccine (Bexsero) against MenB disease into the Brazilian immunization programme." Vaccine 37, no. 45 (October 2019): 6783–86. http://dx.doi.org/10.1016/j.vaccine.2019.09.062.

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Gasparini, Roberto, Paolo Landa, Daniela Amicizia, Giancarlo Icardi, Walter Ricciardi, Chiara de Waure, Elena Tanfani, et al. "Vaccinating Italian infants with a new multicomponent vaccine (Bexsero®) against meningococcal B disease: A cost-effectiveness analysis." Human Vaccines & Immunotherapeutics 12, no. 8 (May 10, 2016): 2148–61. http://dx.doi.org/10.1080/21645515.2016.1160177.

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Pérez-Trallero, Emilio, Olatz Esnal, and José M. Marimón. "Progressive Decrease in the Potential Usefulness of Meningococcal Serogroup B Vaccine (4CMenB, Bexsero®) in Gipuzkoa, Northern Spain." PLoS ONE 9, no. 12 (December 26, 2014): e116024. http://dx.doi.org/10.1371/journal.pone.0116024.

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Carter, Natalie J. "Multicomponent Meningococcal Serogroup B Vaccine (4CMenB; Bexsero®): A Review of its Use in Primary and Booster Vaccination." BioDrugs 27, no. 3 (April 11, 2013): 263–74. http://dx.doi.org/10.1007/s40259-013-0029-2.

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Alashkar, Ferras, Doerte Herich-Terhuerne, Nicole Preising, Ulrich Duehrsen, Vogel Ulrich, and Alexander Röth. "Serologic Response to Meningococcal Vaccination in Patients with Cold Agglutinin Disease (CAD) in the New Era of Complement Inhibition." Blood 132, Supplement 1 (November 29, 2018): 3817. http://dx.doi.org/10.1182/blood-2018-99-118968.

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Abstract BACKGROUND: Cold agglutinin disease (CAD) is an ultra-rare and potentially life-threatening, acquired autoimmune hemolytic anemia. It is characterized by hemagglutination and hemolysis due to immunoglobulin-mediated (usually IgMᴋ) classic complement pathway activation aggravated by infections and exposure to cold environmental temperatures. As conventional approaches are largely ineffective or short term in controlling hemolysis, complement inhibition (CI) (eculizumab-C5, BIVV009-C1s, and APL-2-C3) represents a novel and promising treatment option in these patients (pts). However, due to inhibition of complement cascade, pts are susceptible to encapsulated bacteria, especially N. meningitidis. Therefore, meningococcal vaccination is mandatory on CI to reduce the risk of infection. PATIENTS/METHODS: In this systematic study serologic response to the quadrivalent meningococcal polysaccharide conjugate vaccine (Menveo®) in pts with CAD (n=9; 8 females; mean age, 73 yrs (range 64-80 yrs)) was analyzed prior to vaccination and initiation of CI (eculizumab, DECADE Trial (Röth et. al, Blood 2015; 126:274)) and after vaccination at two distinct time intervals (median, 42 days (range 18-60 days) and median, 193 days (range 156-200 days) by measuring serum bactericidal antibody titers with external rabbit complement (rSBA) against meningococcal serogroups A, C, W135 and Y. In one pt rSBA titers were not assessable at the first interval following vaccination. By definition, serologic protection is defined by a rSBA titer ≥1:8 or a fourfold rise pre- to postvaccination. RESULTS: Serologic response in terms of protective rSBA titers to Menveo® after vaccination varied in CAD pts for the meningococcal serogroups and the different time points: A 25% (2/8), C 25% (2/8), W135 50% (4/8), Y 62% (5/8) at first observation compared to: A 0% (0/9), C 22% (2/9), W135 33% (3/9), Y 44% (4/9) at second rSBA titer measurement, reflecting an early decline in protective rSBA titers to non-protective titers over time (Fig. 1). However, no meningococcal infections have been observed in the analyzed cohort under CI. In pts. with a fourfold rise in rSBA titers pre- to postvaccination the beneficial role of conjugated meningococcal vaccinations in contrast to unconjugated vaccines, resembled by increased immunity with booster vaccinations and an anticipated enhanced duration of protection, might further be supported. SUMMARY/CONCLUSIONS: Efficiency of meningococcal vaccines for the different serogroups in CAD pts varies significantly and serological response analyses, especially in the currently recruiting CAD-Trials (BIVV009 and APL-2) addressing CI, are useful. By now, revaccination with the tetravalent conjugate vaccine (Menveo®) every 3 years is recommended. However, the associated risks with long-term CI are presently unknown and might be individually based on serologic response analyses to vaccination, which might even imply additional booster vaccination in pts on chronic CI. Physicians and pts must be vigilant for meningococcal infections at all times. A stand-by therapy with ciprofloxacin 750 mg p.o. in case of signs of meningococcal infection should be recommended with immediate medical evaluation and treatment. The availability of the novel vaccines covering serogroup B (Bexsero®, Trumenba®) may further reduce the risk of infections and should be mandatory in these pts, despite no current test exists to measure serologic response to meningococcal serogroup B on chronic CI. Disclosures Duehrsen: AbbVie: Consultancy, Honoraria; Amgen: Research Funding; Celgene: Honoraria, Research Funding; Gilead: Consultancy, Honoraria; Roche: Honoraria, Research Funding; Janssen: Honoraria. Röth:Novartis: Consultancy, Honoraria, Research Funding; Amgen: Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Bioverativ: Consultancy, Honoraria; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding.

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Watson, Philip S., and David P. J. Turner. "Clinical experience with the meningococcal B vaccine, Bexsero ® : Prospects for reducing the burden of meningococcal serogroup B disease." Vaccine 34, no. 7 (February 2016): 875–80. http://dx.doi.org/10.1016/j.vaccine.2015.11.057.

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Nompari, Luca, Serena Orlandini, Benedetta Pasquini, Cristiana Campa, Michele Rovini, Massimo Del Bubba, and Sandra Furlanetto. "Quality by design approach in the development of an ultra-high-performance liquid chromatography method for Bexsero meningococcal group B vaccine." Talanta 178 (February 2018): 552–62. http://dx.doi.org/10.1016/j.talanta.2017.09.077.

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Ladhani, Shamez N., Helen Campbell, Sydel R. Parikh, Vanessa Saliba, Ray Borrow, and Mary Ramsay. "The introduction of the meningococcal B (MenB) vaccine (Bexsero®) into the national infant immunisation programme – New challenges for public health." Journal of Infection 71, no. 6 (December 2015): 611–14. http://dx.doi.org/10.1016/j.jinf.2015.09.035.

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Ladhani, Shamez N., Rebecca Cordery, Sema Mandal, Hannah Christensen, Helen Campbell, Ray Borrow, and Mary E. Ramsay. "Preventing secondary cases of invasive meningococcal capsular group B (MenB) disease using a recently-licensed, multi-component, protein-based vaccine (Bexsero®)." Journal of Infection 69, no. 5 (November 2014): 470–80. http://dx.doi.org/10.1016/j.jinf.2014.07.002.

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Cicconi, Paola, Claire Jones, Esha Sarkar, Laura Silva-Reyes, Paul Klenerman, Catherine de Lara, Claire Hutchings, et al. "First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector–Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults." Clinical Infectious Diseases 70, no. 10 (July 24, 2019): 2073–81. http://dx.doi.org/10.1093/cid/ciz653.

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Abstract Background Respiratory syncytial virus (RSV) disease is a major cause of infant morbidity and mortality. This Phase I, randomized, observer-blind, placebo- and active-controlled study evaluated an investigational vaccine against RSV (ChAd155-RSV) using the viral vector chimpanzee-adenovirus-155, encoding RSV fusion (F), nucleocapsid, and transcription antitermination proteins. Methods Healthy 18–45-year-old adults received ChAd155-RSV, a placebo, or an active control (Bexsero) at Days (D) 0 and 30. An escalation from a low dose (5 × 109 viral particles) to a high dose (5 × 1010 viral particles) occurred after the first 16 participants. Endpoints were solicited/unsolicited and serious adverse events (SAEs), biochemical/hematological parameters, cell-mediated immunogenicity by enzyme-linked immunospot, functional neutralizing antibodies, anti RSV-F immunoglobin (Ig) G, and ChAd155 neutralizing antibodies. Results There were 7 participants who received the ChAd155-RSV low dose, 31 who received the ChAd155-RSV high dose, 19 who received the placebo, and 15 who received the active control. No dose-related toxicity or attributable SAEs at the 1-year follow-up were observed. The RSV-A neutralizing antibodies geometric mean titer ratios (post/pre-immunization) following a high dose were 2.6 (D30) and 2.3 (D60). The ratio of the fold-rise (D0 to D30) in anti-F IgG over the fold-rise in RSV-A–neutralizing antibodies was 1.01. At D7 after the high dose of the study vaccine, the median frequencies of circulating B-cells secreting anti-F antibodies were 133.3/106 (IgG) and 16.7/106 (IgA) in peripheral blood mononuclear cells (PBMCs). The median frequency of RSV-F–specific interferon γ–secreting T-cells after a ChAd155-RSV high dose was 108.3/106 PBMCs at D30, with no increase after the second dose. Conclusions In adults previously naturally exposed to RSV, ChAd155-RSV generated increases in specific humoral and cellular immune responses without raising significant safety concerns. Clinical Trials Registration NCT02491463.

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Bambini, Stefania, Matteo De Chiara, Alessandro Muzzi, Marirosa Mora, Jay Lucidarme, Carina Brehony, Ray Borrow, et al. "Neisseria Adhesin A Variation and Revised Nomenclature Scheme." Clinical and Vaccine Immunology 21, no. 7 (May 7, 2014): 966–71. http://dx.doi.org/10.1128/cvi.00825-13.

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ABSTRACTNeisseriaadhesin A (NadA), involved in the adhesion and invasion ofNeisseria meningitidisinto host tissues, is one of the major components of Bexsero, a novel multicomponent vaccine licensed for protection against meningococcal serogroup B in Europe, Australia, and Canada. NadA has been identified in approximately 30% of clinical isolates and in a much lower proportion of carrier isolates. Three protein variants were originally identified in invasive meningococci and named NadA-1, NadA-2, and NadA-3, whereas most carrier isolates either lacked the gene or harbored a different variant, NadA-4. Further analysis of isolates belonging to the sequence type 213 (ST-213) clonal complex identified NadA-5, which was structurally similar to NadA-4, but more distantly related to NadA-1, -2, and -3. At the time of this writing, more than 89 distinctnadAallele sequences and 43 distinct peptides have been described. Here, we present a revised nomenclature system, taking into account the complete data set, which is compatible with previous classification schemes and is expandable. The main features of this new scheme include (i) the grouping of the previously named NadA-2 and NadA-3 variants into a single NadA-2/3 variant, (ii) the grouping of the previously assigned NadA-4 and NadA-5 variants into a single NadA-4/5 variant, (iii) the introduction of an additional variant (NadA-6), and (iv) the classification of the variants into two main groups, named groups I and II. To facilitate querying of the sequences and submission of new allele sequences, the nucleotide and amino acid sequences are available athttp://pubmlst.org/neisseria/NadA/.

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Le, Trang Thu, Thach Xuan Tran, Long Phi Trieu, Christopher M. Austin, Huong Minh Nguyen, and Dong Van Quyen. "Genotypic characterization and genome comparison reveal insights into potential vaccine coverage and genealogy of Neisseria meningitidis in military camps in Vietnam." PeerJ 8 (July 21, 2020): e9502. http://dx.doi.org/10.7717/peerj.9502.

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Background Neisseria meningitidis remains the main cause of sporadic meningitis and sepsis in military camps in Vietnam. Yet, very limited molecular data of their genotypic and epidemiological characteristics are available from Vietnam, and particularly the military environment. Whole genome sequencing (WGS) has proven useful for meningococcal disease surveillance and guiding preventative vaccination programs. Previously, we characterized key genetic and epidemiological features of an invasive N. meningitidis B isolate from a military unit in Vietnam. Here, we extend these findings by sequencing two additional invasive N. meningitidis B isolated from cerebrospinal fluid (CSF) of two meningitis cases at another military unit and compared their genomic sequences and features. We also report the sequence types and antigenic profiles of 25 historical and more recently emerged N. meningitidis isolates from these units and other units in proximity. Methods Strains were sequenced using the Illumina HiSeq platform, de novo assembled and annotated. Genomes were compared within and between military units, as well as against the global N. meningitidis collection and other isolates from the Southeast Asia region using PubMLST. Variations at the nucleotide level were determined, and phylogenetic relationships were estimated. Antigenic genotypes and vaccine coverage were analyzed using gMATS and PubMLST. Susceptibility of isolates against commonly used antibiotic agents was examined using E-test. Results Genome comparison revealed a high level of similarity among isolates both within and between units. All isolates showed resistance to chloramphenicol and carried identical catP gene with other Southeast Asian isolates, suggesting a common lineage. Their antigenic genotypes predicted no coverage by either Bexsero®or Trumenba®, and nucleotide variation analysis revealed diverse new, unassigned alleles at multiple virulence loci of all strains. Groups of singleton and unique novel sequence types extending beyond individual camps were found from epidemiological data of 25 other isolates. Our results add to the sparse published molecular data of N. meningitidis in the military units in Vietnam, highlight their diversity, distinct genetic features and antibiotic resistance pattern, and emphasize the need for further studies on the molecular characteristics of N. meningitidis in Vietnam.

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Leo, Stefano, Vladimir Lazarevic, Myriam Girard, Gisela C. Getaz-Jimenez Velasco, Nadia Gaïa, Gesuele Renzi, Abdessalam Cherkaoui, Eva Hong, Muhamed-Kheir Taha, and Jacques Schrenzel. "Strain coverage of Bexsero vaccine assessed by whole-genome sequencing over a cohort of invasive meningococci of serogroups B and W isolated in Switzerland." Vaccine 38, no. 33 (July 2020): 5324–31. http://dx.doi.org/10.1016/j.vaccine.2020.05.071.

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Arnold, Louise, Ray Borrow, Kathryn Riley, Talha Munir, Richard Kelly, Rachael Jones, Jeanifer Gachev, et al. "Management of Meningococcal Disease Risk in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) on Complement Inhibitors: 18 Years' Experience from the UK National PNH Service in Leeds." Blood 136, Supplement 1 (November 5, 2020): 5–6. http://dx.doi.org/10.1182/blood-2020-141780.

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Eculizumab, the monoclonal antibody targeting C5, is the only licensed treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) in the UK. Inherent to the mechanism of action, C5 inhibitors increase patient susceptibility to encapsulated microorganisms, particularly Neisseria meningitidis. The PNH National service (UK), has 18 years of experience treating patients with PNH using complement inhibition. The risk of N. meningitidis is mitigated by vaccination, ciprofloxacin (500 mg bd) on days 1-13 since we moved to vaccination on day one of complement inhibitor therapy, followed by daily prophylaxis with penicillin (or erythromycin). Since a case of sepsis with penicillin-resistant meningococci was observed, patients also have a rescue course ciprofloxacin. Patient education, safety cards, prompt action in case of fever and a 24 hour on-call service for patients are equally important. Until 2010 patients were revaccinated with MenACWY every 3 years. Bexsero (MenB vaccine) vaccination (2 vaccines within first 6 months) with boosters every 5 years was added in 2015. In collaboration with the Public Health England Meningococcal Reference Unit in 2010 a program was developed to monitor antibody titers after vaccination and to revaccinate against MenACWY if titers declined to below protective levels. It is technically not possible to assay for meningoccal serogroup B antibody titers when on Eculizumab therapy. We present the outcome of this project. Methods: Antibody titers to serogroups ACWY were assayed following vaccination and then once per annum. Patients with unprotective antibody titers were revaccinated. We evaluate our practice and review the 9 meningococcal infections in 8 patients. We present disease characteristics, serogroup and outcome, vaccination history and antibody status. Results: Between May 2002 and July 2020, 324 patients commenced complement inhibitor treatment for PNH. 801 vaccinations with MenACWY were administered; median 2 vaccinations per patient (range 1 - 10). A total of 1,671 antibody titer assessments were conducted in 294 patients, median of 4 tests per patient (range 1 - 15). Every test assessed antibodies against all four serogroups. Titers were not assessed in 9% of patients (30), due to vaccination prior to change in practice or recent commencement on treatment. A protective antibody response to all serogroups after first vaccination was observed in 170 / 294 patients (57.8%) and a partial response (antibodies to 3 serotypes) in 51 /294 (17.3%). Revaccination of 51 partial responders resulted in an additional 21 patients with a full response. Revaccination of 73 non-responders (antibodies to 0-2 serotypes) resulted in 32 more partial or full responses. 287 of 324 patients received MenB vaccinations; median 2 vaccinations per patient (range 1 - 4). Eight of 324 (2%) patients with median age 22.5 years developed meningococcal sepsis (see table); patient 5 had 2 episodes. 3 of 5 cases with serogroup B infection were before serogroup B vaccination was introduced. The other 4 episodes in 3 patients were due to Y, C, W meningococci, in one the serogroup is unknown. All except patient 1 were compliant with antibiotic prophylaxis. Patient 7 died from meningococcemia, a delay in seeking medical attention may have contributed, however this was also a penicillin resistant strain. Discussion: We report the largest experience of managing meningococcal risk in patients on complement inhibitor therapy for PNH. Despite our proactive management we had 9 cases of meningococcal sepsis, with one fatal infection. Our most recently introduced practice of prompt treatment with ciprofloxacin if pyrexic on antibiotic prophylaxis will prevent cases like patient 7 with a penicillin resistant strain. Three patients had a meningococci sepsis with serogroups C, W and Y; whilst 1 patient had no check of titers due to recent commencement on treatment, the titres of the other 2 had suggested protective immunity. We demonstrated that a full antibody response can be obtained on a second vaccination in most patients if the first one failed. If no response is achieved upfront or revaccination then further MenACWY vaccination is not likely to be successful. Current practice significantly mitigates the risk of meningococcal disease, however it is essential patients remain vigilant for fever, seeking immediate medical attention stating their diagnosis of PNH on complement inhibitor therapy. Disclosures Arnold: Alexion Pharmaceuticals: Honoraria. Borrow:Pfizer: Research Funding; GlaxoSmithKline: Research Funding; Alexion pharmacueticals: Research Funding; Sanofi: Research Funding. Riley:Alexion: Honoraria. Munir:Alexion: Honoraria; F. Hoffmann-La Roche: Consultancy, Other: Medical writing support, furnished by Scott Battle, PhD, of Health Interactions, was funded by F. Hoffmann-La Roche Ltd, Basel, Switzerland. Kelly:Alexion: Honoraria. Pike:Apellis: Research Funding. Hillmen:Acerta: Other: Financial or material support; Roche: Consultancy, Other: Financial or material support, Research Funding, Speakers Bureau; AbbVie: Consultancy, Other: Financial or material support, Research Funding, Speakers Bureau; Pharmacyclics: Other: Financial or material support, Research Funding; Janssen: Consultancy, Other: Financial or material support, Research Funding, Speakers Bureau; AstraZeneca: Consultancy, Speakers Bureau; Gilead: Other: Financial or material support, Research Funding; Alexion: Consultancy, Research Funding, Speakers Bureau; Apellis: Consultancy, Research Funding, Speakers Bureau. Griffin:Alexion Pharmaceuticals: Honoraria, Other: Conference Support; Biocryst: Membership on an entity's Board of Directors or advisory committees.

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Vusqa, Urwat Til, Palash Asawa, Yazan Samhouri, Rama Bhagavatula, and Robert B. Kaplan. "A Challenging Case of Atypical Hemolytic Uremic Syndrome in a Young African American Patient." Blood 138, Supplement 1 (November 5, 2021): 4225. http://dx.doi.org/10.1182/blood-2021-153508.

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Abstract Background It is known that malignant hypertension (mHTN) and thrombotic microangiopathy (TMA) commonly coexist. Deciding which phenomenon preceded the other remains a clinical dilemma, specifically in African American patients. However, making that determination is of utmost importance because the management will be different, and that can have dramatic effects on prognosis and outcomes. Herein, we report a case of atypical hemolytic uremic syndrome (aHUS) presenting as mHTN. Case Presentation A 35-year-old African American male with known history of hypertension, presented with nausea, vomiting, and diarrhea for four days. He also reported fatigue and exertional shortness of breath. Upon presentation, his blood pressure was 260/160 mmHg, otherwise physical exam was unremarkable. Initial work up showed hemoglobin of 8.8 g/dL (baseline 13.5), platelet count of 21,000/mL (baseline 250,000), serum creatinine of 16.99 mg/dL (baseline 0.99), MCV (84 fl), increased reticulocyte production index (3.58), increased LDH (1709 U/L), undetectable haptoglobin, and numerous schistocytes on peripheral blood smear. He was admitted as a case of hypertensive emergency and TMA. IV labetalol and hemodialysis were started. Given his gastrointestinal symptoms; stool for Shigella and E.Coli O157:H7 were checked and they were negative. Given the severity of his hematologic derangements and difficult to control blood pressure, we decided to proceed with renal biopsy to rule out primary aHUS which showed thrombotic microangiopathy, global glomerulosclerosis, moderate interstitial fibrosis and tubular atrophy suggestive of aHUS or rheumatologic disorders like systemic sclerosis and arguing against malignant HTN as the sole player. ANA and anti-Scl-70 antibodies were negative. Final impression was aHUS by exclusion, and patient received meningococcal vaccines (Menactra and Bexsero) in preparation to start eculizumab. aHUS genetic panel was sent which came back equivocal as it showed mutations of unknown significance (homozygous missense mutation in the MASP2 gene and 2 heterozygous mutations in the C2 gene). He was started on eculizumab 900 mg weekly for 4 weeks then 1200 mg biweekly starting week 5. He was seen in the office 2 months after initial presentation and receiving 5 doses of Eculizumab. His kidney function showed improvement with > 2 liters of urine output daily, blood pressure was better controlled. A decision by nephrology was made to give him a break from dialysis and remains dialysis-free a year later. Discussion aHUS is a rare disorder with an estimated prevalence of seven per one million children in Europe. It causes uninhibited activation of complement factors that leads to renal endothelial damage and activation of coagulation cascade leading to TMA. The diagnosis of aHUS requires the fulfillment of the classical triad (microangiopathic hemolytic anemia, thrombocytopenia, and acute renal failure) with a positive gene mutation or antibodies to complement factors. However, absence of these mutations or antibodies, as in the presented case, do not exclude the diagnosis. The early diagnosis of aHUS is necessary for treatment with eculizumab, a monoclonal antibody against C5 to block the terminal complement cascade. Kidney biopsy can be helpful in equivocal cases especially if it shows only the typical changes of malignant hypertension which essentially rules out aHUS. Hypertension with concurrent TMA is treated with strict BP control which is often enough to resolve TMA features and restores renal function, at least partially. On the contrary, aHUS causing severe HTN needs more sophisticated testing and blockade of the terminal complement component to improve outcome; that's why the distinction of which one is the primary process is of utmost importance. Our case emphasizes the importance of having low threshold for testing for aHUS in patients with mHTN and TMA, especially in African American patients where malignant HTN is known to happen more commonly, and to notice the subtle hints that may help in this distinction, such as profound hemolysis or thrombocytopenia out of proportion to what one would expect from mHTN alone. Early recognition of aHUS may save a patient's kidney. Disclosures No relevant conflicts of interest to declare.

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Rollier, Christine S., Christina Dold, Leanne Marsay, Aline Linder, Christopher A. Green, Manish Sadarangani, Gunnstein Norheim, et al. "Human B Cell Responses to Dominant and Subdominant Antigens Induced by a Meningococcal Outer Membrane Vesicle Vaccine in a Phase I Trial." mSphere 7, no. 1 (February 23, 2022). http://dx.doi.org/10.1128/msphere.00674-21.

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Neisseria meningitidis outer membrane vesicles (OMV) are a component of the capsular group B meningococcal vaccine 4CMenB (Bexsero) and have been shown to induce 30% efficacy against gonococcal infection. They are composed of multiple antigens and are considered an interesting delivery platform for vaccines against several bacterial diseases.

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Feavers, Ian M., and Martin C. J. Maiden. "Recent Progress in the Prevention of Serogroup B Meningococcal Disease." Clinical and Vaccine Immunology 24, no. 5 (March 29, 2017). http://dx.doi.org/10.1128/cvi.00566-16.

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ABSTRACT The widespread use of meningococcal polysaccharide conjugate vaccines has highlighted the challenge of providing protection against serogroup B disease. Over a period of 4 decades, vaccine development has focused on subcapsular protein antigens, first with outer membrane vesicle (OMV) vaccines against epidemic outbreaks, and more recently on new multicomponent vaccines designed to offer better cross-protection against the antigenically diverse strains responsible for endemic disease. Because of the low incidence of meningococcal disease, the protective efficacy of these vaccines has not been determined in clinical studies, and their licensure has been based on serological data; however, the serological assays used to predict protective coverage have limitations. As a result, evidence of the effectiveness of these vaccines against different strains and the contribution of specific antigens to protection can only be provided by epidemiological analyses following their implementation in sufficiently large populations. The recent inclusion of the four-component meningococcal serogroup B (4CMenB) vaccine, Bexsero, in the infant immunization program in the UK has provided preliminary evidence that the vaccine is effective. Ongoing surveillance will provide valuable data on its longer-term impact and antigenic coverage. Further development of protein-based vaccines against meningococcal disease is anticipated to improve antigenic coverage and adjust to changes in circulating strains. At the same time, alternative immunization strategies may be explored to improve overall vaccine effectiveness by, for example, protecting the youngest infants or providing herd protection.

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Journal articles on the topic 'BEXERO VACCINE'

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