Journal articles on the topic 'Vaccine schedule and formulation'
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Platt, Andrew, Munir Mosaheb, Adam Gower, and Lee Wetzler. "Transcriptome analysis of N. meningitidis PorB as an adjuvant in a multi-injection vaccination schedule (P4494)." Journal of Immunology 190, no. 1_Supplement (May 1, 2013): 178.1. http://dx.doi.org/10.4049/jimmunol.190.supp.178.1.
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Abstract Vaccines play an integral role in the fight against infectious diseases. Most current vaccines, however, were developed empirically, both in their formulation and schedule. A deeper understanding of the regulatory pathways involved in both adjuvanted vaccines and multi-injection schedules would contribute greatly to the rational design of future vaccines. Here we report a microarray analysis study of a 3 injection vaccination using Neisseria meningitidis PorB as a vaccine adjuvant and an Ova antigen in a murine model. We observe that the kinetics of the response in a number of gene sets is accelerated, with maximal expression after the second vaccination, rather than the third, in the adjuvanted vaccine. We also observe a recruitment of a number of innate inflammatory pathways, with adjuvanted vaccines eliciting more robust gene expression. Main effects and interactions between the antigen and adjuvant were determined, in particular as related and antibody production. In this report we demonstrate that the inclusion of PorB as an adjuvant into the formulation of a vaccine significantly alters the kinetics and nature of the immune response at a deep transcriptional level. This may provide meaningful implications for the rational design of future adjuvanted vaccines.
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Tzeng, Stephany Y., Kevin J. McHugh, Adam M. Behrens, Sviatlana Rose, James L. Sugarman, Shiran Ferber, Robert Langer, and Ana Jaklenec. "Stabilized single-injection inactivated polio vaccine elicits a strong neutralizing immune response." Proceedings of the National Academy of Sciences 115, no. 23 (May 21, 2018): E5269—E5278. http://dx.doi.org/10.1073/pnas.1720970115.
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Vaccination in the developing world is hampered by limited patient access, which prevents individuals from receiving the multiple injections necessary for protective immunity. Here, we developed an injectable microparticle formulation of the inactivated polio vaccine (IPV) that releases multiple pulses of stable antigen over time. To accomplish this, we established an IPV stabilization strategy using cationic polymers for pH modulation to enhance traditional small-molecule–based stabilization methods. We investigated the mechanism of this strategy and showed that it was broadly applicable to all three antigens in IPV. Our lead formulations released two bursts of IPV 1 month apart, mimicking a typical vaccination schedule in the developing world. One injection of the controlled-release formulations elicited a similar or better neutralizing response in rats, considered the correlate of protection in humans, than multiple injections of liquid vaccine. This single-administration vaccine strategy has the potential to improve vaccine coverage in the developing world.
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Pettini, Elena, Gabiria Pastore, Fabio Fiorino, Donata Medaglini, and Annalisa Ciabattini. "Short or Long Interval between Priming and Boosting: Does It Impact on the Vaccine Immunogenicity?" Vaccines 9, no. 3 (March 20, 2021): 289. http://dx.doi.org/10.3390/vaccines9030289.
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Characterizing the impact of the vaccination schedule on the induction of B and T cell immune responses is critical for improving vaccine immunogenicity. Here we compare the effect of a short (4 weeks) or a long (18 weeks) interval between priming and boosting in mice, using a model vaccine formulation based on the chimeric tuberculosis vaccine antigen H56 combined with alum. While no significant difference was observed in serum antigen-specific IgG response and the induction of antigen-specific T follicular helper cells into draining lymph nodes after the two immunization schedules, a longer interval between priming and boosting elicited a higher number of germinal center-B cells and H56-specific antibody-secreting cells and modulated the effector function of reactivated CD4+ T cells. These data show that the scheduling of the booster immunization could affect the immune response elicited by vaccination modulating and improving the immunogenicity of the vaccine.
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Trevisan, Andrea, Paola Mason, Annamaria Nicolli, Stefano Maso, Bruno Scarpa, Angelo Moretto, and Maria Luisa Scapellato. "Vaccination and Immunity toward Measles: A Serosurvey in Future Healthcare Workers." Vaccines 9, no. 4 (April 13, 2021): 377. http://dx.doi.org/10.3390/vaccines9040377.
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Measles is a very contagious infectious disease, and vaccination is the only medical aid to counter the spread of the infection. The aim of this study was to evaluate the influence of vaccination schedule and type of vaccine, number of doses, and sex on the immune response. In a population of Italian medical students (8497 individuals born after 1980 with certificate of vaccination and quantitative measurement of antibodies against measles), the prevalence of positive antibodies to measles and antibody titer was measured. Vaccination schedule such as number of doses and vaccine type (measles alone or combined as measles, mumps and rubella (MMR)) and sex were the variables considered to influence the immune response. The vaccination schedule depends on the year of birth: students born before 1990 were prevalently vaccinated once and with measles vaccine alone (not as MMR). One dose of vaccine induces a significantly (p < 0.0001) higher positive response and antibody titer than two doses, in particular when measles alone is used (p < 0.0001). Females have a significantly higher percentage of positive response (p = 0.0001) than males but only when the MMR formulation was used. Multiple linear regression confirms that sex significantly influences antibody titer when only MMR is used, after one (p = 0.0002) or two (p = 0.0060) doses. In conclusion, vaccination schedule and, partially, sex influence immune response to measles vaccination. Most notably, the measles vaccine alone (one dose) is more effective than one and two doses of MMR.
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Aguilar, Julio Cesar, Jorge Agustin Aguiar, and Sheikh Mohammad Fazle Akbar. "Action Mechanisms and Scientific Rationale of Using Nasal Vaccine (HeberNasvac) for the Treatment of Chronic Hepatitis B." Vaccines 10, no. 12 (December 7, 2022): 2087. http://dx.doi.org/10.3390/vaccines10122087.
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Nasvac (HeberNasvac®) is a novel therapeutic vaccine for chronic hepatitis B (CHB). This product is a formulation of the core (HBcAg) and surface (HBsAg) antigens of the hepatitis B virus (HBV), administered by nasal and subcutaneous routes, in a distinctive schedule of immunizations. In the present review article, we discuss the action mechanisms of HeberNasvac, considering the immunological properties of the product and their antigens. Specifically, we discuss the capacity of HBcAg to activate different pathways of innate immunity and the signal transduction after a multi-TLR agonist effect, and we review the results of recent clinical trials and in vitro studies. Aimed at understanding the clinical results of Nasvac and other therapeutic vaccines under development, we discuss the rationale of administering a therapeutic vaccine through the nasal route and also the current alternatives to combine therapeutic vaccines and antivirals (NUCs). We also disclose potential applications of this product in novel fields of immunotherapy.
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Cajaraville, Ana Carolina dos Reis Albuquerque, Mariana Pierre de Barros Gomes, Tamiris Azamor, Renata Carvalho Pereira, Patrícia Cristina da Costa Neves, Paula Mello De Luca, Sheila Maria Barbosa de Lima, et al. "Evaluation of Two Adjuvant Formulations for an Inactivated Yellow Fever 17DD Vaccine Candidate in Mice." Vaccines 11, no. 1 (December 28, 2022): 73. http://dx.doi.org/10.3390/vaccines11010073.
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The attenuated yellow fever (YF) vaccine is one of the most successful vaccines ever developed. After a single dose administration YF vaccine can induce balanced Th1/Th2 immune responses and long-lasting neutralizing antibodies. These attributes endorsed it as a model of how to properly stimulate the innate response to target protective immune responses. Despite their longstanding success, attenuated YF vaccines can cause rare fatal adverse events and are contraindicated for persons with immunosuppression, egg allergy and age < 6 months and >60 years. These drawbacks have encouraged the development of a non-live vaccine. The aim of the present study is to characterize and compare the immunological profile of two adjuvant formulations of an inactivated YF 17DD vaccine candidate. Inactivated YF vaccine formulations based on alum (Al(OH)3) or squalene (AddaVax®) were investigated by immunization of C57BL/6 mice in 3-dose or 2-dose schedules, respectively, and compared with a single dose of attenuated YF virus 17DD. Sera were analyzed by ELISA and Plaque Reduction Neutralization Test (PRNT) for detection of total IgG and neutralizing antibodies against YF virus. In addition, splenocytes were collected to evaluate cellular responses by ELISpot. Both inactivated formulations were able to induce high titers of IgG against YF, although neutralizing antibodies levels were borderline on pre-challenge samples. Analysis of IgG subtypes revealed a predominance of IgG2a associated with improved neutralizing capacity in animals immunized with the attenuated YF vaccine, and a predominance of IgG1 in groups immunized with experimental non-live formulations (alum and AddaVax®). After intracerebral (IC) challenge, attenuated and inactivated vaccine formulations showed an increase in neutralizing antibodies. The AddaVax®-based inactivated vaccine and the attenuated vaccine achieved 100% protection, and alum-based equivalent formulation achieved 70% protection.
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Meneveau, Max O., Pankaj Kumar, Kevin T. Lynch, Sapna P. Patel, and Craig L. Slingluff. "The vaccine-site microenvironment: impacts of antigen, adjuvant, and same-site vaccination on antigen presentation and immune signaling." Journal for ImmunoTherapy of Cancer 10, no. 3 (March 2022): e003533. http://dx.doi.org/10.1136/jitc-2021-003533.
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BackgroundA goal of cancer vaccines is to induce strong T cell responses to tumor antigens, but the delivery method, schedule, and formulation of cancer vaccines have not yet been optimized. Adjuvants serve to increase the immune response against vaccine antigens. However, little is known about the impact of adjuvants plus antigen and their delivery schedule on the immunologic milieu in the vaccine-site microenvironment (VSME). We hypothesized that antigen processing and presentation may occur directly in the VSME, that adding the toll-like receptor 3 (TLR3) agonist polyICLC (pICLC) would enhance markers of immune activation, and that the immune signatures would be enhanced further by repeated vaccination in the same skin site rather than after multiple vaccines in different skin locations.MethodsUsing RNA sequencing, we evaluated VSME biopsies from patients undergoing subcutaneous/intradermal peptide vaccination against melanoma, with incomplete Freund’s adjuvant (IFA) with or without pICLC. Differential gene expression analyses and gene set enrichment analyses were performed using R. False discovery rate corrected p values <0.05 were considered significant.ResultsWe found that addition of peptide antigens to IFA enhanced antigen presentation pathways and a tertiary lymphoid structure gene-signature locally at the VSME. Addition of pICLC to IFA + peptide induced an immunologically favorable VSME 1 week after injection but had little impact on the VSME after three injections, compared with IFA + peptide alone. Repeated same-site injection of IFA + peptide antigens induced a VSME with more dendritic cell activation, Th1 dominance, and TLR adaptor protein gene expression than that induced by injections at different, rotating skin locations.ConclusionsThese data suggest that the vaccine-site itself may be a critically important location contributing to vaccine immunity rather than just the draining lymph node, that IFA induces a favorable VSME with TLR agonist being most beneficial early in the vaccine course, and that same-site injections lead to persistent stimulation of immune pathways that may be beneficial in eliciting antigen specific T cell expansion.
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Niemuth, Nancy A., Carol L. Sabourin, and Lucy A. Ward. "Adapting Simon’s Two-Stage Design for Efficient Screening of Filovirus Vaccines in Non-Human Primates." Vaccines 10, no. 8 (July 29, 2022): 1216. http://dx.doi.org/10.3390/vaccines10081216.
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The cynomolgus monkey (Macaca fascicularis) non-human primate (NHP) is widely used for filovirus vaccine testing. To use limited BSL-4 resources efficiently and minimize NHP usage, Simon’s two-stage design was adapted to screen candidate Ebola virus (EBOV) vaccines in up to six NHPs with two (optimal), three, or four NHPs in Stage 1. Using the optimal design, two NHPs were tested in Stage 1. If neither survived, the candidate was rejected. Otherwise, it was eligible for Stage 2 testing in four NHPs. Candidates advanced if four or more NHPs were protected over both stages. An 80% efficacious candidate vaccine had 88.5% probability of advancing, and a 40% efficacious candidate vaccine had 83% probability of rejection. Simon’s two-stage design was used to screen 27 EBOV vaccine candidates in 43 candidate regimens that varied in dose, adjuvant, formulation, or schedule. Of the 30 candidate regimens tested using two NHPs in Stage 1, 15 were rejected, nine were withdrawn, and six were tested in Stage 2. All six tested in Stage 2 qualified to advance in the product development pipeline. Multiple regimens for the EBOV vaccines approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in 2019 were tested in this program. This approach may also prove useful for screening Sudan virus (SUDV) and Marburg virus (MARV) vaccine candidates.
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Bekele, Yonas, Jay A. Berzofsky, and Francesca Chiodi. "Undetectable Anti-HBs Antibodies: Need of a Booster Dose for HIV-1-Infected Individuals." Vaccines 9, no. 12 (December 15, 2021): 1484. http://dx.doi.org/10.3390/vaccines9121484.
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HBV vaccination effectively prevents HBV transmission and the development of liver cancer. Disease progression and liver-related complications are more common in HIV-1/HBV co-infected than HBV mono-infected individuals. A considerable body of literature, which will be reviewed here, indicates that response to HBV vaccine is suboptimal in HIV-1-infected individuals and that the poor maintenance of protective immunity to HBV vaccines in these individuals is an important medical issue. Several factors affect HBV vaccine response during HIV-1 infection including CD4+ T cell counts, B cell response, vaccine formulation, schedules, and timing of antiretroviral therapy (ART). The initial response to HBV vaccination also plays a critical role in the sustainability of antibody responses in both HIV-1-infected and uninfected vaccinees. Thus, regular follow-up for antibody titer and a booster dose is warranted to prevent HBV transmission in HIV-1 infected people.
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Mabel Cruz, Rodríguez, Báez Gretchen Bergado, Luna Yerandy Hechevarría, Fernández Diana Rosa Hernández, Palomo Addys González, Suárez Narjara González, Castillo Carlos Yordan González, Lorenzo María del Carmen Luzardo, García Lisset Chao, and Ramírez Belinda Sánchez. "The combination of very-small size proteoliposomes and alum is a safe adjuvant alternative for inducing anti-EGF antibodies: a preclinical study." Archives of Cancer Science and Therapy 6, no. 1 (September 20, 2022): 018–30. http://dx.doi.org/10.29328/journal.acst.1001029.
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Immunization with human recombinant EGF chemically bound to the P64k protein of Neisseria meningitides (hrEGF-P64k) and adjuvanted in Montanide ISA 51 VG (Montanide) is an efficient strategy to induce polyclonal antibodies (PAbs) response targeting this self -antigen in cancer patients, which is the basis of the CIMAvax-EGF vaccine. The neutralizing potential of EGF-specific induced PAbs supports promising clinical data obtained to date with this vaccine. Herein, we evaluated a combination of very small-size proteoliposomes (VSSP) and aluminum hydroxide (Alum) as a novel adjuvant to induce specific PAbs with neutralizing and anti-proliferative properties on tumor cells, considering EGF as a model antigen. Toxicity at the injection site was not detected for the vaccine formulation containing VSSP/Alum, and it was immunogenic in BALB/c mice, as evidenced by the induction of high titers of EGF-specific polyclonal antibodies (PAbs). While schedule optimization increased the magnitude of the PAbs response induced by VSSP/Alum, induced PAbs’s avidity and intrinsic neutralizing potential were comparable to the humoral response induced by Montanide. Also, VSSP addition switched IgG subclasses distribution into a Th1-like pattern, as obtained with Montanide and desirable for a cancer vaccine. Finally, equivalent PAbs titers were induced by the vaccine formulations adjuvanted in VSSP/Alum or Montanide in tumor-bearing-mice, and immunosuppressed mice, suggesting the feasibility of the VSSP/Alum combined adjuvant for inducing anti-EGF antibodies in cancer patients at advanced stages of the disease.
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Johnston, Sara C., Keersten M. Ricks, Ines Lakhal-Naouar, Alexandra Jay, Caroline Subra, Jo Lynne Raymond, Hannah A. D. King, et al. "A SARS-CoV-2 Spike Ferritin Nanoparticle Vaccine Is Protective and Promotes a Strong Immunological Response in the Cynomolgus Macaque Coronavirus Disease 2019 (COVID-19) Model." Vaccines 10, no. 5 (May 4, 2022): 717. http://dx.doi.org/10.3390/vaccines10050717.
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The COVID-19 pandemic has had a staggering impact on social, economic, and public health systems worldwide. Vaccine development and mobilization against SARS-CoV-2 (the etiologic agent of COVID-19) has been rapid. However, novel strategies are still necessary to slow the pandemic, and this includes new approaches to vaccine development and/or delivery that will improve vaccination compliance and demonstrate efficacy against emerging variants. Here, we report on the immunogenicity and efficacy of a SARS-CoV-2 vaccine comprising stabilized, pre-fusion spike protein trimers displayed on a ferritin nanoparticle (SpFN) adjuvanted with either conventional aluminum hydroxide or the Army Liposomal Formulation QS-21 (ALFQ) in a cynomolgus macaque COVID-19 model. Vaccination resulted in robust cell-mediated and humoral responses and a significant reduction in lung lesions following SARS-CoV-2 infection. The strength of the immune response suggests that dose sparing through reduced or single dosing in primates may be possible with this vaccine. Overall, the data support further evaluation of SpFN as a SARS-CoV-2 protein-based vaccine candidate with attention to fractional dosing and schedule optimization.
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Lawrence, Jody, Nicholas Kitchin, Annaliesa S. Anderson, Michael W. Pride, Kathrin U. Jansen, William C. Gruber, Yahong Peng, Kevin Yi, Charles Knirsch, and Chris Webber. "12. Randomized Studies of Two Clostridioides (Clostridium) difficile Vaccine Formulations." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S29. http://dx.doi.org/10.1093/ofid/ofaa439.057.
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Abstract Background Two formulations of investigational bivalent Clostridioides (Clostridium) difficile vaccine (QS-21 adjuvanted toxoid and toxoid-alone) were assessed for safety and immunogenicity in randomized studies in healthy adults 50–85 years of age. Methods The Phase 1 study of QS-21 adjuvanted toxoid vaccine randomized subjects 3:1 to 100 μg QS-21-containing C difficile vaccine or placebo; 3 doses were given according to 2 different schedules: a shortened month (Months 0, 1, 3) or day (Days 1, 8, 30) regimen. The Phase 2 toxoid-alone vaccine study randomized subjects 3:3:1 to receive 100 or 200 μg unadjuvanted C difficile vaccine formulation or placebo in Stages 1 and 2 (sentinel cohorts of different age groups), and 3:1 to receive the selected dose of unadjuvanted C difficile vaccine formulation or placebo in Stage 3. Three doses were given on a day (Days 1, 8, 30) regimen. Safety was the primary outcome for both studies. Immunogenicity was determined by measuring serum toxin A– and B–specific neutralizing antibodies. Results In the day regimen, 10 reports across both studies of grade 3 injection site redness postdose 2 triggered predefined stopping rules. Local reactions in both studies were more common among vaccine versus placebo recipients. Injection site pain predominated and was generally mild in severity. Systemic events were infrequent and generally mild-to-moderate in severity. Adverse events were reported by 50.0%–75.0% and 16.7%–50.0% of subjects in the QS-21 and toxoid-alone studies, respectively. Immune responses peaked around Day 37 (shortened-month regimen) or between Day 15 and Month 2 (day regimen), and remained above baseline throughout follow-up. Conclusion Both formulations demonstrated robust immunogenicity. However, both studies stopped early due to grade 3 injection site redness postdose 2 of the day (Days 1, 8, 30) regimen; neither formulation progressed to later stage development. Instead, an aluminum hydroxide-containing formulation of the vaccine candidate administered at 0, 1, and 6 months, which was safe and immunogenic in phase 1 and 2 studies, advanced to phase 3 studies. Disclosures Jody Lawrence, MD, Pfizer, Inc (Employee) Nicholas Kitchin, MD, Pfizer, Inc (Employee) Annaliesa S. Anderson, PhD, Pfizer (Employee, Shareholder) Michael W. Pride, PhD, Pfizer (Employee, Shareholder) Kathrin U. Jansen, PhD, Pfizer (Employee, Shareholder) William C. Gruber, MD, Pfizer (Employee, Shareholder) Yahong Peng, PhD, Pfizer (Employee, Shareholder) Charles Knirsch, MD, Pfizer (Employee) Chris Webber, MD, Pfizer Inc (Employee, Shareholder)
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Honda-Okubo, Yoshikazu, Jeremy Baldwin, and Nikolai Petrovsky. "Advax-CpG Adjuvant Provides Antigen Dose-Sparing and Enhanced Immunogenicity for Inactivated Poliomyelitis Virus Vaccines." Pathogens 10, no. 5 (April 21, 2021): 500. http://dx.doi.org/10.3390/pathogens10050500.
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Global immunization campaigns have resulted in a major decline in the global incidence of polio cases, with wild-type poliovirus remaining endemic in only two countries. Live oral polio vaccine (OPV) played a role in the reduction in polio case numbers; however, the risk of OPV developing into circulating vaccine-derived poliovirus makes it unsuitable for eradication programs. Trivalent inactivated polio virus (TIPV) vaccines which contain formalin-inactivated antigens produced from virulent types 1, 2 and 3 reference polio strains grown in Vero monkey kidney cells have been advocated as a replacement for OPV; however, TIPVs have weak immunogenicity and multiple boosts are required before peak neutralizing titers are reached. This study examined whether the incorporation of the novel polysaccharide adjuvant, Advax-CpG, could boost the immunogenicity of two TIPV vaccines, (i) a commercially available polio vaccine (IPOL®, Sanofi Pasteur) and (ii) a new TIPV formulation developed by Statens Serum Institut (SSI). Mice were immunized intramuscularly based on recommended vaccine dosage schedules and serum antibody titers were followed for 12 months post-immunization. Advax-CpG significantly enhanced the long-term immunogenicity of both TIPV vaccines and had at least a 10-fold antigen dose-sparing effect. An exception was the poor ability of the SSI TIPV to induce serotype type 1 neutralizing antibodies. Immunization with monovalent IPVs suggested that the low type 1 response to TIPV may be due to antigen competition when the type 1 antigen was co-formulated with the type 2 and 3 antigens. This study provides valuable insights into the complexity of the formulation of multivalent polio vaccines and supports the further development of adjuvanted antigen-sparing TIPV vaccines in the fight to eradicate polio.
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Lopez, Pio, Yolanda Caicedo, Alexandra Sierra, Sandrine Tilman, Ralf Clemens, and Angelika Banzhoff. "Combined Administration of MF59-Adjuvanted A/H5N1 Prepandemic and Seasonal Influenza Vaccines: Long-Term Antibody Persistence and Robust Booster Responses 1 Year after a One-Dose Priming Schedule." Clinical and Vaccine Immunology 20, no. 5 (March 27, 2013): 753–58. http://dx.doi.org/10.1128/cvi.00626-12.
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ABSTRACTHaving previously demonstrated the feasibility of administering A/H5N1 and seasonal influenza vaccine antigens in an MF59-adjuvanted tetravalent formulation, we now report on long-term antibody persistence and responses to a booster dose of a combined seasonal-pandemic, tetravalent influenza vaccine in adults. The primary objective was the evaluation of responses to a booster dose of tetravalent influenza vaccine containing seasonal (A/H1N1, A/H3N2, and B) and avian (A/H5N1, clade 2) influenza virus strains administered to 265 healthy 18- to 40-year-old volunteers 1 year after priming with one or two clade 1 A/H5N1 doses. Secondary objectives were assessment of reactogenicity, safety, and antibody persistence 1 year after priming with a combined seasonal-pandemic, tetravalent vaccine. Responses to seasonal strains met all European licensure criteria; seroprotection rates were 94 to 100%, 100%, and 61 to 90% for A/H1N1, A/H3N2, and B strains, respectively. Anamnestic responses were observed against homologous and heterologous A/H5N1 strains whether priming with one or two A/H5N1 doses, with a monovalent A/H5N1 vaccine, or with a tetravalent vaccine. A single dose of MF59-adjuvanted A/H5N1 vaccine given alone or as part of a fixed combination with a seasonal influenza vaccine was sufficient to prime adult subjects, resulting in robust antigen-specific and cross-reactive antibody responses to heterologous booster immunization 1 year later. These data support the feasibility of incorporating prepandemic priming into seasonal influenza vaccination programs. (This study has been registered at clinicaltrials.gov under registration no. NCT00481065.)
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Moon, James E., Christian Ockenhouse, Jason A. Regules, Johan Vekemans, Cynthia Lee, Ilin Chuang, Magali Traskine, et al. "A Phase IIa Controlled Human Malaria Infection and Immunogenicity Study of RTS,S/AS01E and RTS,S/AS01B Delayed Fractional Dose Regimens in Malaria-Naive Adults." Journal of Infectious Diseases 222, no. 10 (July 20, 2020): 1681–91. http://dx.doi.org/10.1093/infdis/jiaa421.
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Abstract Background A previous RTS,S/AS01B vaccine challenge trial demonstrated that a 3-dose (0-1-7–month) regimen with a fractional third dose can produce high vaccine efficacy (VE) in adults challenged 3 weeks after vaccination. This study explored the VE of different delayed fractional dose regimens of adult and pediatric RTS,S/AS01 formulations. Methods A total of 130 participants were randomized into 5 groups. Four groups received 3 doses of RTS,S/AS01B or RTS,S/AS01E on a 0-1-7–month schedule, with the final 1 or 2 doses being fractional (one-fifth dose volume). One group received 1 full (month 0) and 1 fractional (month 7) dose of RTS,S/AS01E. Immunized and unvaccinated control participants underwent Plasmodium falciparum–infected mosquito challenge (controlled human malaria infection) 3 months after immunization, a timing chosen to potentially discriminate VEs between groups. Results The VE of 3-dose formulations ranged from 55% (95% confidence interval, 27%–72%) to 76% (48%–89%). Groups administered equivalent formulations of RTS,S/AS01E and RTS,S/AS01B demonstrated comparable VE. The 2-dose group demonstrated lower VE (29% [95% confidence interval, 6%–46%]). All regimens were well tolerated and immunogenic, with trends toward higher anti-circumsporozoite antibody titers in participants protected against infection. Conclusions RTS,S/AS01E can provide VE comparable to an equivalent RTS,S/AS01B regimen in adults, suggesting a universal formulation may be considered. Results also suggest that the 2-dose regimen is inferior to the 3-dose regimens evaluated. Clinical Trial Registration NCT03162614
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Ellis, John, Elizabeth Marziani, Chumkee Aziz, Catherine M. Brown, Leah A. Cohn, Christopher Lea, George E. Moore, and Neha Taneja. "2022 AAHA Canine Vaccination Guidelines." Journal of the American Animal Hospital Association 58, no. 5 (September 1, 2022): 213–30. http://dx.doi.org/10.5326/jaaha-ms-canine-vaccination-guidelines.
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ABSTRACT These guidelines are an update and extension of previous AAHA peer-reviewed canine vaccination guidelines published in 2017. Vaccination is a cornerstone of canine preventive healthcare and one of the most cost-effective ways of maintaining a dog’s health, longevity, and quality of life. Canine vaccination also serves a public health function by forming a barrier against several zoonotic diseases affecting dogs and humans. Canine vaccines are broadly categorized as containing core and noncore immunizing antigens, with administration recommendations based on assessment of individual patient risk factors. The guidelines include a comprehensive table listing canine core and noncore vaccines and a recommended vaccination and revaccination schedule for each vaccine. The guidelines explain the relevance of different vaccine formulations, including those containing modified-live virus, inactivated, and recombinant immunizing agents. Factors that potentially affect vaccine efficacy are addressed, including the patient’s prevaccination immune status and vaccine duration of immunity. Because animal shelters are one of the most challenging environments for prevention and control of infectious diseases, the guidelines also provide recommendations for vaccination of dogs presented at or housed in animal shelters, including the appropriate response to an infectious disease outbreak in the shelter setting. The guidelines explain how practitioners can interpret a patient’s serological status, including maternally derived antibody titers, as indicators of immune status and suitability for vaccination. Other topics covered include factors associated with postvaccination adverse events, vaccine storage and handling to preserve product efficacy, interpreting product labeling to ensure proper vaccine use, and using client education and healthcare team training to raise awareness of the importance of vaccinations.
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Park, Min-Hye, Ji Won You, Hyoung Jin Kim, and Hong-Jin Kim. "IgG and IgM responses to human papillomavirus L1 virus-like particle as a function of dosing schedule and vaccine formulation." Journal of Microbiology 57, no. 9 (August 27, 2019): 821–27. http://dx.doi.org/10.1007/s12275-019-9308-z.
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Bendandi, Maurizio, Carlos Becerra, Joseph Kuhn, Suncica Hukic, Nyla Langford, Taizoon Khokhar, Victor Klimyuk, et al. "Idiotypic Vaccination of Patients with Relapsed Follicular Lymphoma Using a Novel Vaccine Formulation Including a Tobacco Plant-Produced Tumor Specific Idiotype." Blood 118, no. 21 (November 18, 2011): 1649. http://dx.doi.org/10.1182/blood.v118.21.1649.1649.
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Abstract Abstract 1649 Idiotypic vaccination has shown evidence of biological efficacy, clinical efficacy and clinical benefit in some subsets of patients with follicular lymphoma. A phase-I clinical trial is currently being conducted to assess safety and immunogenicity of a novel, recombinant idiotype vaccine in which the idiotype protein is produced in tobacco plants. Previous animal and clinical studies with plant-produced single-chain variable fragment lymphoma vaccines have demonstrated specific immunogenicity and safety. However, the expression levels of such fragments were highly variable and required complex engineering of the linkers. Moreover, the downstream processing could not be built around standard methods like protein A affinity capture. Our novel vaccine manufacturing process by magnICONR technology is devoid of such shortcomings and allows consistent and efficient expression in plants of idiotype-containing, whole immunoglobulins. Safety and tolerability of the novel vaccine formulation is the subject of this report. Patients eligible for the study are those with relapsed follicular lymphoma whose prior treatment has included rituximab. Patients receive salvage therapy with bendamustine and prednisone. Use of rituximab is prohibited on this trial due to the prolonged B-cell depletion that characteristically follows its administration. Subjects enrolled in the study who achieve and maintain either a complete (CR) or partial (PR) response for at least 4 months following BP therapy undergo idiotype vaccination. Six patients have received a variable number of monthly doses of the novel, first-in-human, magnICONR produced idiotype vaccine. Each dose includes a conjugate of 0.5 mg of idiotype and 0.5 mg of keyhole limpet hemocyanin on day 1. A dose of 0.125mg of GM-CSF is administered with the idiotype vaccine on day 1 and alone subcutaneously at the same injection site on day 2 through 4. Each vaccination cycle is repeated every four weeks. The vaccination schedule as defined by the protocol outlines eight monthly vaccination cycles followed by four bi-monthly vaccination cycles for a total of 12 vaccinations. No patient has yet completed the entire vaccination protocol and no patient has relapsed/progressed while receiving vaccine. Two patients have received eight vaccinations. The remaining four patients have received five, four, two and one vaccination, respectively. The patient who received two vaccinations was removed from the study after the development of progressive multifocal leukoencephalopathy Undefined symptoms had appeared prior to the initiation of vaccine and PML was subsequently attributed to previous, prolonged maintenance treatment with rituximab received prior to the enrollment in this clinical trial. Toxicity data are available for 28 doses of idiotype vaccine. There has been no grade 4–5 hematologic and non-hematologic toxicity. Grade 3 non-hematologic toxicity was recorded in 1/6 (17%) patients and in 1/28 (4%) cycles, respectively, consisting of generalized pain during one day. Grade 1–2 non-hematologic toxicities were recorded in all six patients and virtually in all cycles. The most common of them were fatigue, pain at the injection site, myalgia, diarrhea, headache and generalized pain. Grade 3 hematologic toxicity was recorded in 2/6 (33%) patients and in 2/28 (7%) cycles, respectively, and consisted predominantly of leucopenia. Grade 1–2 hematologic toxicities were common, most often consisting of anemia and thrombocytopenia. These preliminary data indicate that this novel idiotype vaccine is well tolerated in patients with relapsed follicular lymphoma following chemotherapy with BP. Studies of vaccine-induced humoral and cellular immune responses are ongoing. Results will be updated at the time of the meeting. The authors wish to acknowledge Drs. Ralph Heaven, Larry Barker, Jairo Olivares, Thomas Anderson, Carl Chakmakjian, Barry Cooper, Amir Faridi, Vinay Jain, Pankaj Khandelwal, Janice Marshall, Anton Melnyk, Robert Mennel, James Turner. Disclosures: No relevant conflicts of interest to declare.
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Tricou, Vianney, Shibadas Biswal, Mengya Liu, Sanjay S. Patel, Olaf Zent, Martina Rauscher, Gonzalo Perez, Walid Kandeil, and Nicolas Folschweiller. "97. Tetravalent Dengue Vaccine (TAK-003) Development Program: A Bird’s Eye View." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S61. http://dx.doi.org/10.1093/ofid/ofab466.097.
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Abstract Background Dengue fever is a mosquito-borne viral disease endemic in 128 countries. An unmet clinical need remains for an effective vaccine that can be used more broadly than the vaccine presently available. A clinical development program has evaluated the long-term safety, immunogenicity, and vaccine efficacy (VE) of TAK-003, a live attenuated tetravalent dengue vaccine with a DENV-2 backbone engineered to elicit immune responses to all 4 dengue serotypes. Methods 18 clinical trials in 13 countries have involved 28,175 seropositive/seronegative participants aged from 1.5-60 years from endemic/non-endemic regions. In the ongoing pivotal phase III study, 4–16-year-old healthy children (N=20,099) were randomized 2:1 to receive two doses of TAK-003 or placebo, 3 months apart for an evaluation of VE and safety over a multi-year period stratified pre-vaccination dengue serostatus. Active surveillance throughout the trial detected symptomatic dengue. The trial will continue up to 4–4.5 years post 2nd dose, and for another 25 months after a booster dose. Data up to 3 years after the second vaccination are currently available. Results Safety and immunogenicity data from Phase I/II studies established the final formulation and dosing schedule. Overall VE in the pivotal phase III study was 80.2% [95% CI: 73.3–85.3] against virologically confirmed dengue (VCD) at 12 months post 2nd dose. At 18 months, VE was 66.2% (95% CI: 49.1–77.5) in dengue-naive and 76.1% (95% CI: 68.5–81.9) in dengue pre-exposed participants, with VE of 90.4% (95% CI: 82.6–94.7) and 85.9% (95% CI: 31.9–97.1) for prevention of hospitalized VCD and dengue hemorrhagic fever, respectively. Cumulative VE against VCD from first dose to 3 years post 2nd dose was 62.0% (95% CI: 56.6–66.7) and 83.6% (95% CI: 76.8–88.4) in prevention of hospitalized VCD. Some decline in VE was observed over time mainly driven by outpatient dengue. Two doses of TAK-003 3 months apart were well-tolerated with no important safety risks identified up to 3 years after completion of the vaccination schedule. Conclusion TAK-003 is immunogenic against all 4 dengue serotypes and continues to be efficacious, well-tolerated, and with no evidence of disease enhancement in seronegative population up to 3 years post-vaccination. Disclosures Vianney Tricou, D Phil, Takeda Pharmaceuticals International (Employee) Shibadas Biswal, MD, Takeda Vaccines, Inc (Employee) Sanjay S. Patel, PhD, Takeda Pharmaceuticals International AG (Employee) Olaf Zent, MD, Takeda Pharmaceuticals International AG (Employee) Martina Rauscher, PhD, Takeda Pharmaceuticals International AG (Employee) Gonzalo Perez, MD, Takeda group companies (Employee) Walid Kandeil, MD, Takeda Pharmaceuticals International AG (Employee) Nicolas Folschweiller, PhD, Takeda (Employee)
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Flick-Smith, Helen C., Jim E. Eyles, Richard Hebdon, Emma L. Waters, Richard J. Beedham, Tony J. Stagg, Julie Miller, H. Oya Alpar, Les W. J. Baillie, and E. Diane Williamson. "Mucosal or Parenteral Administration of Microsphere-Associated Bacillus anthracis Protective Antigen Protects against Anthrax Infection in Mice." Infection and Immunity 70, no. 4 (April 2002): 2022–28. http://dx.doi.org/10.1128/iai.70.4.2022-2028.2002.
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ABSTRACT Existing licensed anthrax vaccines are administered parenterally and require multiple doses to induce protective immunity. This requires trained personnel and is not the optimum route for stimulating a mucosal immune response. Microencapsulation of vaccine antigens offers a number of advantages over traditional vaccine formulations, including stability without refrigeration and the potential for utilizing less invasive routes of administration. Recombinant protective antigen (rPA), the dominant antigen for protection against anthrax infection, was encapsulated in poly-l-lactide 100-kDa microspheres. Alternatively, rPA was loosely attached to the surfaces of microspheres by lyophilization. All of the microspheric formulations were administered to A/J mice with a two-dose schedule by either the intramuscular route, the intranasal route, or a combination of these two routes, and immunogenicity and protective efficacy were assessed. An intramuscular priming immunization followed by either an intramuscular or intranasal boost gave optimum anti-rPA immunoglobulin G titers. Despite differences in rPA-specific antibody titers, all immunized mice survived an injected challenge consisting of 103 median lethal doses of Bacillus anthracis STI spores. Immunization with microencapsulated and microsphere-associated formulations of rPA also protected against aerosol challenge with 30 median lethal doses of STI spores. These results show that rPA can be encapsulated and surface bound to polymeric microspheres without impairing its immunogenicity and also that mucosal or parenteral administration of microspheric formulations of rPA efficiently protects mice against both injected and aerosol challenges with B. anthracis spores. Microspheric formulations of rPA could represent the next generation of anthrax vaccines, which could require fewer doses because they are more potent, are less reactogenic than currently available human anthrax vaccines, and could be self-administered without injection.
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de Bruyn, Guy, Jamshid Saleh, David Workman, Richard Pollak, Victor Elinoff, Neil J. Fraser, Gigi Lefebvre, et al. "Defining the optimal formulation and schedule of a candidate toxoid vaccine against Clostridium difficile infection: A randomized Phase 2 clinical trial." Vaccine 34, no. 19 (April 2016): 2170–78. http://dx.doi.org/10.1016/j.vaccine.2016.03.028.
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Bonvehí, Pablo, Dominique Boutriau, Javier Casellas, Vincent Weynants, Christiane Feron, and Jan Poolman. "Three Doses of an Experimental Detoxified L3-Derived Lipooligosaccharide Meningococcal Vaccine Offer Good Safety but Low Immunogenicity in Healthy Young Adults." Clinical and Vaccine Immunology 17, no. 9 (July 21, 2010): 1460–66. http://dx.doi.org/10.1128/cvi.00129-10.
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ABSTRACT This open, randomized phase I study evaluated the safety and reactogenicity of an experimental meningococcal serogroup B (MenB) vaccine obtained from outer membrane vesicle detoxified L3-derived lipooligosaccharide. Healthy young adults (n = 150) were randomized to receive either experimental vaccine (provided in five formulations, n = 25 in each group) or VA-Mengoc-BC (control, n = 25) administered on a 0- to 6-week/6-month schedule. Serum bactericidal assays performed against three MenB wild-type strains assessed the immune response, defined as a 4-fold increase from pre- to postvaccination. No serious adverse events related to vaccination were reported. Pain at the injection site, fatigue, and headache were the most commonly reported adverse events. Solicited adverse events graded level 3 (i.e., preventing daily activity) were pain (up to 17% of the test subjects versus 32% of the controls), fatigue (up to 12% of the test subjects versus 8% of the controls), and headache (up to 4% of any group). Swelling graded level 3 (greater than 50 mm) occurred in up to 4% of the test subjects versus 8% of the controls. The immune responses ranged from 5% to 36% across experimental vaccines for the L3 H44-76 strain (versus 27% for the control), from 0% to 11% for the L3 NZ98/124 strain (versus 23% for the control), and from 0% to 13% for the L2 760676 strain (versus 59% for the control). All geometric mean titers were below those measured with the control vaccine. The five experimental formulations were safe and well tolerated but tended to be less immunogenic than the control vaccine.
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Armbruster, Jasny, and Petsch. "Advances in RNA Vaccines for Preventive Indications: A Case Study of A Vaccine Against Rabies." Vaccines 7, no. 4 (September 27, 2019): 132. http://dx.doi.org/10.3390/vaccines7040132.
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: There is a global need for effective and affordable rabies vaccines, which is unmet by current vaccines due to limitations in their production capacities, required administration schedules, storage requirements, and cost. Many different experimental approaches previously used for bacterial and viral vaccines have been applied to rabies, but with variable success. One of the most promising new concepts is the use of messenger RNA (mRNA) in encoding the main rabies virus antigen, the envelope glycoprotein (RABV-G). CureVac has applied their proprietary technology platform for the production of mRNA to this problem, resulting in the rabies vaccine candidate CV7201. Following preclinical studies in mice and pigs showing that CV7201 could induce neutralizing immune responses that protected against rabies virus, different dosages and routes of administration of CV7201 were tested in a phase 1 human study. This clinical study proved that mRNA vaccination was safe and had an acceptable reactogenicity profile, but immune responses depended on the mode of administration, and they did not unequivocally support CV7201 for further development as a prophylactic vaccine with this particular formulation. Further, preclinical studies using RABV-G mRNA encapsulated in lipid nanoparticles (LNPs) showed an improved response in both mice and nonhuman primates, and these encouraging results are currently being followed up in clinical studies in humans. This review summarizes the recent advances in mRNA vaccines against rabies.
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Butler, Anne M., Jason Newland, John Sahrmann, Caroline O’Neil, Sena Sayood, and Leah McGrath. "1383. Characterizing Real-world Patterns of Early Childhood Vaccination." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S701. http://dx.doi.org/10.1093/ofid/ofaa439.1565.
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Abstract Background Vaccine hesitancy is increasingly common, but more information is needed on patterns of childhood vaccination. We characterized patterns of vaccine delay among commercially-insured children in the U.S. Methods Using the IBM MarketScan Commercial Database, we identified infants who received a timely first dose of diphtheria-tetanus-acellular pertussis (DTaP) vaccine from October 2009 to June 2017. We used CPT codes to collect vaccine administration history on antigen, formulation, dose, and date. We ascertained injectable and oral vaccine antigens (DTaP, polio, pneumococcal conjugate, rotavirus, Haemophilus influenza type b (Hib), measles, mumps, rubella, varicella). Timely receipt was defined as concomitant administration of the CDC-recommended number of antigens during the following time windows: 2, 4, 6, and 12-15 months of age (grace period: -7, +21 days). We generated heat maps to illustrate age distributions at receipt of specific antigens and doses. We created Sankey diagrams to illustrate the number of antigens received concomitantly during each time window and depict transitions to different states over time (e.g., no vaccine delay to vaccine delay). For each antigen and dose, we estimated the cumulative incidence of receipt. Results Among 1,066,216 eligible infants, the majority (84%) concomitantly received all 5 CDC-recommended antigens at 2 months of age while others only received 1 (1%), 2 (2%), 3 (4%) or 4 (9%) antigens. Many vaccinations were delayed – 30% and 39% of children did not receive all recommended antigens concomitantly at 4 and 6 months, respectively. The heat map shows wide variation in age at vaccination. For several antigens including Hib, measles, mumps, rotavirus, rubella, and varicella, the cumulative incidence increased steeply at ≥2 time points, suggesting vaccine delay for some infants (e.g., the first dose of Hib was administered to 85% of infants by 2 months of age, with subsequent small but distinct increases at 4, 6, 12, and 15 months of age). Conclusion Using real-world data to study early childhood vaccination patterns, we observed evidence of substantial deviation from the CDC-recommended schedule. These results expand current knowledge on the magnitude and timing of antigen- and dose-specific vaccine delay on a population level. Disclosures Jason Newland, MD, MEd, FPIDS, Merck (Grant/Research Support)Pfizer (Other Financial or Material Support, Industry funded clinical trial) Leah McGrath, PhD, NoviSci, Inc. (Employee)
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Wieczorek, Lindsay, Shelly J. Krebs, Vaniambadi Kalyanaraman, Stephen Whitney, Sodsai Tovanabutra, Carlos G. Moscoso, Eric Sanders-Buell, et al. "Comparable Antigenicity and Immunogenicity of Oligomeric Forms of a Novel, Acute HIV-1 Subtype C gp145 Envelope for Use in Preclinical and Clinical Vaccine Research." Journal of Virology 89, no. 15 (May 13, 2015): 7478–93. http://dx.doi.org/10.1128/jvi.00412-15.
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ABSTRACTEliciting broadly reactive functional antibodies remains a challenge in human immunodeficiency virus type 1 (HIV-1) vaccine development that is complicated by variations in envelope (Env) subtype and structure. The majority of new global HIV-1 infections are subtype C, and novel antigenic properties have been described for subtype C Env proteins. Thus, an HIV-1 subtype C Env protein (CO6980v0c22) from an infected person in the acute phase (Fiebig stage I/II) was developed as a research reagent and candidate immunogen. The gp145 envelope is a novel immunogen with a fully intact membrane-proximal external region (MPER), extended by a polylysine tail. Soluble gp145 was enriched for trimers that yielded the expected “fan blade” motifs when visualized by cryoelectron microscopy. CO6980v0c22 gp145 reacts with the 4E10, PG9, PG16, and VRC01 HIV-1 neutralizing monoclonal antibodies (MAbs), as well as the V1/V2-specific PGT121, 697, 2158, and 2297 MAbs. Different gp145 oligomers were tested for immunogenicity in rabbits, and purified dimers, trimers, and larger multimers elicited similar levels of cross-subtype binding and neutralizing antibodies to tier 1 and some tier 2 viruses. Immunized rabbit sera did not neutralize the highly resistant CO6980v0c22 pseudovirus but did inhibit the homologous infectious molecular clone in a peripheral blood mononuclear cell (PBMC) assay. This Env is currently in good manufacturing practice (GMP) production to be made available for use as a clinical research tool and further evaluation as a candidate vaccine.IMPORTANCEAt present, the product pipeline for HIV vaccines is insufficient and is limited by inadequate capacity to produce large quantities of vaccine to standards required for human clinical trials. Such products are required to evaluate critical questions of vaccine formulation, route, dosing, and schedule, as well as to establish vaccine efficacy. The gp145 Env protein presented in this study forms physical trimers, binds to many of the well-characterized broad neutralizing MAbs that target conserved Env epitopes, and induce cross-subtype neutralizing antibodies as measured in both cell line and primary cell assays. This subtype C Env gp145 protein is currently undergoing good manufacturing practice production for use as a reagent for preclinical studies and for human clinical research. This product will serve as a reagent for comparative studies and may represent a next-generation candidate HIV immunogen.
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Nisar, Muhammad Imran, Fyezah Jehan, Shahira Shahid, Sheraz Ahmed, Sadia Shakoor, Furqan Kabir, Aneeta Hotwani, et al. "Serotype-specific effectiveness against pneumococcal carriage and serotype replacement after ten-valent Pneumococcal Conjugate Vaccine (PCV10) introduction in Pakistan." PLOS ONE 17, no. 1 (January 21, 2022): e0262466. http://dx.doi.org/10.1371/journal.pone.0262466.
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Objective Pakistan was one of the first South-Asian countries to introduce the ten-valent pneumococcal conjugate vaccine (PCV10) at the national level, using a 3+0 schedule without catchup, in 2013. Methods From 2014–18, fifteen children <2 years old were recruited every week in Matiari, Sindh, and nasopharyngeal swabs were collected. The samples were cultured, and pneumococcus was further serotyped through multiplex PCR at the Aga Khan University Hospital as per the method described by the Centers for Disease Control and Prevention, USA. Results Pneumococcus was detected in 2370/3140 (75%) children. Vaccine type (VT) and non-vaccine type (NVT) serotypes were carried by 379 and 1990 children. There was a significant decline in VT carriage (by 40.3%, p-value <0.001), whereas overall NVT carriage remained the same. The prevalence of VT serotypes 6B, 9V/9A, and 19F showed a significant decline by 58.8%, 79.3%, and 56%, respectively. The prevalence of NVT serotypes 19A, 21, and 10A increased by 70%, 33.3%, and 65.6%, respectively, whereas serotypes 13 and 9N/9L decreased by 53.4% and 51.8%, respectively. Serotype-specific vaccine effectiveness estimates that reached statistical significance were for 9V/9A (VE = 65.0, 95% CI 26.0–83.5%), 19F (VE = 55.3, 95% CI 15.5–76.4%) and for the vaccine related serotype 6A (VE = 28.4, 95% CI 0.9–48.2%). Conclusion The emergence of NVT serotypes, primarily 19A replacing VT serotypes in this rural community, necessitates continuous monitoring of serotypes in the carriage and invasive disease to evaluate the utility of existing vaccine formulations.
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Kouenkam, Jean Pierre II, Joseph Mbang, and Yves Emvudu. "Global dynamics of a model of hepatitis B virus infection in a sub-Saharan African rural area." International Journal of Biomathematics 13, no. 06 (July 23, 2020): 2050054. http://dx.doi.org/10.1142/s1793524520500540.
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We formulate and systematically study a deterministic compartmental model of Hepatitis B. This model has some important and novel features compared with the well-known basic model in the literature. Specifically, it takes into account the differential susceptibility that follows the vaccine formulation employing three-doses schedule. It points up the HbeAg status of carriers, their levels of viral replication, the fact that treatment being not curative is recommended only to a small proportion of chronic carriers, and finally the fact that only inactive carriers are able to recover from disease. The model has simple dynamical behavior which has a globally asymptotically stable disease-free equilibrium when the basic reproduction number [Formula: see text] and an endemic equilibrium when [Formula: see text]. By the use of Lyapunov functions, when it exists, we prove the global asymptotic stability of the endemic equilibrium under some conditions. Using data from Tokombere, a rural area in Cameroon, numerical simulations are performed. These numerical simulations first confirm analytical results, second they suggest that a policy based on treatment could not significantly impact the course of the infection. Third, they show as it is well known that vaccination is a very effective measure to control the infection. Furthermore, they show that neonatal vaccination influences more the course of infection than mass vaccination strategy. Nevertheless, they picture how much loss between consecutive doses of vaccine could be harmful. Finally, it is suggested that for a Sub-saharan African rural area, two-thirds of expected incidence of Hepatitis B virus infection and one third of expected prevalence of chronic carriers could be averted by 2030 if the birth dose vaccination becomes systematic and if mass vaccination rate increases to up 10%.
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Huang, Haibin, Gary R. Ostroff, Chrono K. Lee, Charles A. Specht, and Stuart M. Levitz. "Characterization and Optimization of the Glucan Particle-Based Vaccine Platform." Clinical and Vaccine Immunology 20, no. 10 (August 14, 2013): 1585–91. http://dx.doi.org/10.1128/cvi.00463-13.
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ABSTRACTGlucan particles (GPs) are hollow porousSaccharomyces cerevisiaecell walls that are treated so that they are composed primarily of β-1,3-d-glucans. Our previous studies showed that GPs can serve as an effective vaccine platform. Here, we characterize CD4+T-cell and antibody responses in immunized mice as a function of antigen (ovalbumin) encapsulation, antigen dose, particle numbers, time, immunization schedule, and trapping methods. Although we found that GPs served as an effective adjuvant when admixed with free antigens for IgG1 antibody production, stronger CD4+T-cell and IgG2c antibody responses were stimulated when antigens were encapsulated inside GPs, suggesting that the GP platform acts as both an adjuvant and a delivery system. Vigorous T-cell and antibody responses were stimulated even at submicrogram antigen doses, as long as the number of GPs was kept at 5 × 107particles per immunization. One prime and one boost were sufficient to elicit robust immune responses. In addition, strong antigen-specific antibody and T-cell responses prevailed up to 20 months following the last immunization, including those of gamma interferon (IFN-γ), interleukin 17A (IL-17A), and dual IFN-γ/IL-17A-secreting CD4+T cells. Finally, robust immune responses were observed using generally recognized as safe (GRAS) materials (alginate and calcium, with or without chitosan) to trap antigens within GPs. Thus, these studies demonstrate that antigens encapsulated into GPs make an effective vaccine platform that combines adjuvanticity and antigen delivery to elicit strong durable immune responses at relatively low antigen doses using translationally relevant formulations.
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Babicki, Mateusz. "Will Bivalent Vaccination against COVID-19 Increase the Desire for COVID-19 Vaccination among Poles?" Vaccines 10, no. 10 (October 3, 2022): 1658. http://dx.doi.org/10.3390/vaccines10101658.
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Tduration of persistent protection after vaccination against COVID-19 is the sum of many factors, including the used formulation, the vaccination schedule, individual predisposition, clinical status and the SARS-CoV-2 variant. (There is a tendency that?) vaccination regimens demonstrate lower levels of immunity against the currently predominant Omicron variant, which results in the need for subsequent booster doses. Thus, bivalent formulations have been recently developed to additionally target the Omicron variant. Accordingly, the purpose of this study was to assess whether bivalent vaccines would increase interest in vaccination among Poles. For this purpose, an original questionnaire distributed via the Internet and targeting Poles over the age of 18 was used. Results: The survey included 594 respondents, the vast majority of whom were women (79.3%), residents of large cities (44.7%) and those with a university education (86.3%). The average age was 36.6 ± 9.67 years. Only 48.7% of respondents had heard of bivalent vaccination against COVID-19. 408 (72.3%) respondents confirmed that if they had the choice, they would opt for the bivalent preparation. People who have already taken at least 1 booster dose are by far the most common group. Among the unvaccinated, the percentage is only 8.9%. For 190 (33.7%) of respondents, the availability of bivalent preparations will help accelerate their decision to vaccinate against COVID-19. Conclusions: Bivalent vaccination is an important part of the fight against the ongoing COVID-19 pandemic. However, it is forecasted that its implementation will not contribute significantly to the increase in vaccination-related interest rate among those previously unvaccinated or only after the basic regimen. Therefore further observations in this direction are necessary.
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Soulieres, D., C. Smith, P. M. Ellis, N. Murray, K. Jasas, A. Maksymiuk, G. Goss, M. H. Falk, and C. Butts. "A multi-centre, open-label study to assess the safety of Stimuvax (BLP25 liposome vaccine or L-BLP25) in non-small cell lung cancer (NSCLC) patients (pts) with unresectable stage III disease." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 3075. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.3075.
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3075 Background: L-BLP25 is an innovative cancer vaccine that incorporates a synthetic MUC1 lipopeptide in a liposomal delivery system. L-BLP25 is expected to elicit an immune response to cancer cells that express MUC1. Previous clinical studies have demonstrated that L-BLP25 has the potential to extend survival of pts with stage IIIB locoregional NSCLC (Butts C et al., JCO 2005; 23:6674–6681). The present ph I-II study was designed to assess the safety of the current formulation of L-BLP25 using a monophosphoryl lipid A in pts with unresectable stage IIIA and stage IIIB NSCLC. Methods: Pts with stable disease or an objective response to upfront radical therapy with chemoradiation for unresectable stage III NSCLC, plus ECOG 0–1 were eligible. All pts were vaccinated according to a previously described schedule (1). Maintenance immunizations were administered every 6-wks until disease progression. Primary and secondary endpoints were safety and survival respectively. Results: Twenty-two pts were recruited at 7 sites in Canada. 16 pts were evaluated for this interim safety analysis (8 stage IIIA, 8 stage IIIB, median age; 57, ECOG 0 56%, concurrent chemotherapy; 93.8%). Thirteen pts had a partial response and 3 had stable disease following chemoradiation. Thirteen pts experienced an adverse event (AE) during the first 4 vaccinations of which 7 pts had a L-BLP25 related adverse event. Grade 1/2 AEs related to L-BLP25 ≥10% included fatigue, dyspnea, insomnia, anorexia, headache, diarrhea, paresthesia, abdominal pain, influenza-like illness, urinary tract infection and peripheral neuropathy. No pts discontinued L-BLP25 due to an AE and no grade 3/4 AEs related to L-BLP25 were reported. Six pts (37.5%) had an injection site reaction. As of September 2006, 10 pts were still on study treatment. Conclusions: This formulation of L-BLP25 was well tolerated and the side effect profile was similar to that seen in previous studies (1). A controlled global multi-center phase III trial is underway to further evaluate L-BLP25 in this patient population. No significant financial relationships to disclose.
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Tica, Jelena, Javier Ruiz Guiñazú, Charles P. Andrews, Matthew G. Davis, Brandon Essink, Charles Fogarty, Edward Kerwin, et al. "119. A Respiratory Syncytial Virus Prefusion F Protein (RSVPreF3) Candidate Vaccine Administered in Older Adults in a Phase I/II Randomized Clinical Trial Is Well Tolerated." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S187—S188. http://dx.doi.org/10.1093/ofid/ofaa439.429.
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Abstract Background RSV is a common cause of respiratory acute illness in older adults (OA). We evaluated safety and reactogenicity of RSVPreF3 candidate vaccine in young adults (YA) and OA. Methods In this phase I/II, placebo-controlled, multi-country trial (NCT03814590), YA aged 18–40 years were randomized 1:1:1:1 and received 2 doses of Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted vaccine, or placebo, 2 months apart. Following favorable safety evaluation, a staggered enrolment with 2 steps followed in OA aged 60–80 years, who were randomized 1:1:1:1:1:1:1:1:1:1 to receive 1 of the 9 RSV vaccine formulations containing Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted or adjuvanted with AS01E or AS01B, or placebo (same schedule). Safety/reactogenicity up to 1 month post-dose 1 are reported here. Results Exposed set was comprised of 48 YA and 1005 OA. Within 7 days post-dose 1, any solicited/unsolicited adverse event (AE) ranged from 58.3% to 83.3% across YA vaccinees (placebo YA: 58.3%) and from 29.9% to 84.2% across OA vaccinees (placebo OA: 33.7%) (Fig 1). Pain was the most common solicited local AE, being reported in ≤ 58.3% of YA (placebo YA: 0.0%) and at higher rates in the adjuvanted groups (≤ 75.7%) vs non-adjuvanted groups of OA (≤ 14.1%) and placebo OA (4.1%) (Fig 2A). Of solicited general AEs, fatigue (YA: ≤ 41.7% in vaccinees vs 50.0% in placebo; OA: ≤ 48.5% in vaccinees vs 16.3% in placebo) and headache (YA: ≤ 33.3% in vaccinees vs 16.7% in placebo; OA: ≤ 27.7% in vaccinees vs 8.2% in placebo) were most commonly reported (Fig 2B), while fever ≥ 38.0 °C was observed in ≤ 3.0% of OA vaccinees (placebo OA: 0.0%). Grade 3 solicited local and general AEs were observed in OA only, with erythema (≤ 4.9% in vaccinees vs 0.0% in placebo) and fatigue (≤ 2.0% in vaccinees vs 1.0% in placebo) being most common (Fig 2). No serious AEs (SAEs) were reported in YA. A number of 11 OA reported a SAE within 1 month post-dose 1, but none was fatal or assessed as vaccine-related. No clinically significant abnormalities occurred in hematological/biochemical parameters in any group. Figure 1. Percentage of participants presenting at least one type of solicited/unsolicited adverse event (AE) within 7 days post-dose 1 Figure 2. Percentage of participants with at least one type of solicited adverse event (AE) within 7 days post-dose 1 Conclusion First dose of RSVPreF3 candidate vaccine is well tolerated. AE rates tended to be higher after AS01B-adjuvanted formulations compared to other vaccine formulations. No safety concerns were raised. Funding GlaxoSmithKline Biologicals SA Disclosures Jelena Tica, PhD, GSK group of companies (Employee, Shareholder) Javier Ruiz Guiñazú, MD MSc, GSK group of companies (Employee, Shareholder) Charles P. Andrews, MD, GSK group of companies (Scientific Research Study Investigator) Charles Fogarty, MD, GSK group of companies (Grant/Research Support) Edward Kerwin, MD, Amphastar (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)AstraZeneca (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Boehringer Ingelheim (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Chiesi (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Cipla (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)GSK group of companies (Employee, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Mylan (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Novartis (Employee, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)other around 40 pharmaceutical companies (Other Financial or Material Support, conducted multicenter clinical research trials)Pearl (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Sunovion (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Theravance (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Isabel Leroux-Roels, MD PhD, GSK group of companies (Scientific Research Study Investigator) Corinne Vandermeulen, MD PhD, GSK group of companies (Other Financial or Material Support, My university only received Grant/Research Support) Marie-Pierre David, MSc, GSK group of companies (Employee, Shareholder) Nancy Dezutter, PhD, PharmD, RPh, GSK group of companies (Employee, Shareholder) Laurence Fissette, MSc, GSK group of companies (Employee) Juliane Koch, MD, GSK group of companies (Employee, Shareholder) Narcisa Mesaros, MD, MSc, GSK group of companies (Employee)
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Zanella, Beatrice, Angela Bechini, Benedetta Bonito, Marco Del Riccio, Alessandra Ninci, Emilia Tiscione, Paolo Bonanni, and Sara Boccalini. "A Study of Varicella Seroprevalence in a Pediatric and Adolescent Population in Florence (Italy). Natural Infection and Vaccination-Acquired Immunization." Vaccines 9, no. 2 (February 14, 2021): 152. http://dx.doi.org/10.3390/vaccines9020152.
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Background: Varicella is a well-known infectious disease that can have severe complications, also in young children. The Universal Varicella Vaccination (UVV) program was introduced in Tuscany (Italy) in 2003, with a two-dose vaccine schedule given to children between their 13th and 15th month, and at 5–6 years old, as a monovalent for varicella (V) or tetravalent (measles, mumps, rubella and varicella (MMRV)) formulation. Although varicella notifications have dramatically fallen in the last two decades, varicella disease underreporting remains a challenge. Methods: A qualitative immunoenzymatic test (ELISA) was used to measure the presence of anti-varicella antibodies in 165 sera of subjects aged 1–18 years residing in the province of Florence (Italy). Information regarding the anamnestic and vaccination status (including disease notification) was also collected. Results: Our study showed an overall varicella seropositivity of 75.8% (reaching the maximum at 96.3% in the 15–18 years age group). We found that varicella disease notification had been recorded for only 7/165 subjects; however, since 42/165 recalled having had the disease, we can hypothesize that some of them must have been underreported. Furthermore, our study showed that the presence of antibodies after the varicella vaccination remained over time, lasting up to 12 years. Conclusions: Although varicella seroprevalence is <95% in almost all our age groups (except for the 15–18 years age group), our data are encouraging and reflect the success of the introduction of the UVV program and the vaccination campaigns promoted in the Tuscany region.
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Guiñazú, Javier Ruiz, Jelena Tica, Charles P. Andrews, Matthew G. Davis, Philippe De Smedt, Brandon Essink, Charles Fogarty, et al. "121. A Respiratory Syncytial Virus Prefusion F Protein (RSVPreF3) Candidate Vaccine Administered in Older Adults in a Phase I/II Randomized Clinical Trial Is Immunogenic." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S188—S189. http://dx.doi.org/10.1093/ofid/ofaa439.431.
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Abstract Background RSV causes significant disease burden in older adults, since reinfections are common and may lead to severe disease presentations while only supportive treatment is available. We present immunogenicity of different formulations of an investigational vaccine (RSVPreF3) in young and older adults. Methods This is a phase I/II, placebo-controlled, multi-country trial (NCT03814590). Healthy adults aged 18–40 years were randomized 1:1:1:1 to receive 2 doses of either Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted vaccine or placebo, 2 months apart. Following favorable safety outcomes, adults aged 60–80 years were randomized 1:1:1:1:1:1:1:1:1:1 in a 2-step staggered manner to receive 1 of the 9 RSV vaccine formulations containing Low-, Medium- or High-dose of RSVPreF3, non-adjuvanted or adjuvanted with AS01E or AS01B, or placebo (same schedule). Humoral and cellular-mediated immune responses are assessed before and after each dose; results up to 1 month post-dose 1 are shown here. Results Of 48 adults aged 18–40 years and 1005 aged 60–80 years included in the exposed set, 42 and 933, respectively, were part of per-protocol set at 1 month post-dose 1. RSVPreF3 IgG geometric mean antibody concentrations were 8.4–13.5 and 7.2–12.8 fold-higher at 1 month post-dose 1 vs baseline in the 18–40- and 60–80-year-old vaccinees, respectively (Fig 1A). RSV-A neutralization activity significantly increased in all RSV vaccinees, geometric mean antibody titers being 7.5–13.7 and 5.6–9.9 fold-higher in 18–40- and 60–80-year-olds, respectively, at 1 month post-dose 1 vs baseline (Fig 1B). Geometric mean ratios of the fold increase between RSVPreF3 IgG antibody concentrations and RSV-A neutralizing antibody titers ranged between 0.9–1.1 in 18–40-year-old and 1.3–1.5 in 60–80-year-old vaccinees. A robust RSVPreF3-specific CD4+ T-cell response was elicited at 1 month post-dose 1 vs baseline in both 18–40- and 60–80-year-olds (Fig 2). Figure 1. RSVPreF3 IgG geometric mean antibody concentrations (GMCs, enzyme-linked immunosorbent assay, panel A), RSV-A neutralizing geometric mean antibody titers (GMTs, neutralization assay, panel B) Figure 2. RSVPreF3-specific CD4+ T-cells identified as expressing ≥2 markers among IL2, CD40L, TNF-□, IFN-□ (intracellular cytokine staining assay) Conclusion One dose of RSVPreF3 candidate vaccine boosted humoral and cellular immune responses in all vaccinees. In older adults, higher humoral response, mostly neutralizing, was observed with increased RSVPreF3 antigen dosage and a tendency of higher cellular response was observed after adjuvanted formulations. Funding GlaxoSmithKline Biologicals SA Disclosures Javier Ruiz Guiñazú, MD MSc, GSK group of companies (Employee, Shareholder) Jelena Tica, PhD, GSK group of companies (Employee, Shareholder) Charles P. Andrews, MD, GSK group of companies (Scientific Research Study Investigator) Charles Fogarty, MD, GSK group of companies (Grant/Research Support) Edward Kerwin, MD, Amphastar (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)AstraZeneca (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Boehringer Ingelheim (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Chiesi (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Cipla (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)GSK group of companies (Employee, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Mylan (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Novartis (Employee, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)other around 40 pharmaceutical companies (Other Financial or Material Support, conducted multicenter clinical research trials)Pearl (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Sunovion (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau)Theravance (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Isabel Leroux-Roels, MD PhD, GSK group of companies (Scientific Research Study Investigator) Corinne Vandermeulen, MD PhD, GSK group of companies (Other Financial or Material Support, My university only received Grant/Research Support) Marie-Pierre David, MSc, GSK group of companies (Employee, Shareholder) Nancy Dezutter, PhD, PharmD, RPh, GSK group of companies (Employee, Shareholder) Nathalie De Schrevel, PhD, GSK group of companies (Employee) Laurence Fissette, MSc, GSK group of companies (Employee) Narcisa Mesaros, MD, MSc, GSK group of companies (Employee)
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Ridad, Geraldine Sabate. "BARRIERS TO ADHERENCE TO EXPANDED PROGRAM ON IMMUNIZATION AMONG PARENTS IN LANAO DEL NORTE, PHILIPPINES." Belitung Nursing Journal 5, no. 1 (February 13, 2019): 16–22. http://dx.doi.org/10.33546/bnj.695.
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Background: The Expanded Program on Immunization (EPI) was developed to ensure access of infant and children to recommended vaccines. In the Philippines, nurses are deployed in the community to ensure that children in their assigned units are fully immunized before they reach 1 year old. However, despite the various immunization campaigns, many children still remain unprotected and at-risk to life-threatening vaccine-preventable diseases. Thus, identifying the barriers that have averted parents from adhering to complete and timely immunization is important, most especially to nurses who are the primary program implementers in the community.Objective: This study chiefly aimed to determine the respondents’ perceived barriers along the aspects of Personal, Geographical and Social Barriers, Beliefs and Myths on Immunization, and Knowledge and Awareness on EPI and their relationship to the respondents’ level of adherence to immunization.Methods: Descriptive correlational design was used to explore the perceived barriers to immunization and examine its relationship to the respondents’ level of adherence. A researcher-constructed questionnaire was used after being pilot tested to gather data from 352 random respondents.Results: Using frequency counts, percentages, and weighted arithmetic mean, the results showed that most of the respondents considered only geographical factors as barrier along with social factors. Moreover, it has been found out that respondents lacked knowledge and awareness on the benefits of immunization, the number of vaccines their child needs to receive, site and schedule, side-effects, and contraindications. However, with mean above 2.34 indicated that respondents were informed on the appropriate interventions for side-effects of vaccines, as well as their right to refuse vaccination. The respondents’ over-all level of adherence was moderate.Conclusion: The identified barriers geographical, social, personal, beliefs and myths on immunization and respondents’ level of knowledge and awareness have influenced respondents’ level of adherence to a moderate level only. Based on the results, health care providers, especially nurses, and other concerned program implementers need to consider and address these barriers when formulating or improving strategies to increase immunization compliance. Lastly, more intentional follow-up campaign drives in spreading information about Expanded Program on Immunization using media and other ways is needed.
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Conti, Andrea, Gaia Broglia, Chiara Sacchi, Fabrizia Risi, Francesco Barone-Adesi, and Massimiliano Panella. "Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis." Vaccines 11, no. 1 (January 13, 2023): 178. http://dx.doi.org/10.3390/vaccines11010178.
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Over the last decades, different quadrivalent antimeningococcal vaccine formulations (diphteria toxoid conjugate, MenACWY-D; tetanus toxoid conjugate, MenACWY-TT; CRM197 protein conjugate, MenACWY-CRM) have been developed. However, their availability varies, both in terms of authorized formulations and of inclusion in vaccination schedules. Furthermore, several countries include only the monovalent meningococcal C (MenC) vaccine in their immunization programmes. Finally, there is currently no updated systematic review that directly compares the MenACWY formulations. Thus, we summarized the evidence on efficacy and safety through four parallel, independent systematic literature reviews with meta-analysis which included randomized controlled trials comparing the abovementioned vaccines. A total of 16 studies have been included. In terms of efficacy, MenACWY-TT outperformed MenACWY-D and MenACWY-CRM for A, W-135, and Y serogroups, while no significant difference was found for serogroup C. Furthermore, we did not find significant differences in efficacy between MenC and MenACWY-TT. Regarding the safety, we were able to perform a quantitative analysis only between MenACWY-TT and MenC, finding no significant differences. Similarly, among the different MenACWY formulations no relevant differences were identified. These findings suggest that MenACWY-TT could be preferable to other formulations to improve current vaccination programs and to better develop future immunization policies.
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Navarrete, Marcelo A., Kristina Heining-Mikesch, Cristina Bertinetti-Lapatki, Marcus Duehren-von Minden, Andrea Hafkemeyer, and Hendrik Veelken. "Idiotype Vaccination of Untreated Indolent B-Cell Lymphoma: Durable Objective Remissions and Association of Superior Outcome with Cellular Immune Responses." Blood 112, no. 11 (November 16, 2008): 235. http://dx.doi.org/10.1182/blood.v112.11.235.235.
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Abstract Idiotype vaccination refers to active immunization of B-cell lymphoma (B-NHL) patients with the clonal immunoglobulin (Ig) expressed by the tumor cells. After systemic cytoreductive therapy, idiotype vaccination has been shown to induce specific cellular and humoral immune responses; and humoral responses in particular are associated with prolonged remission and encouraging survival rates. Conventional idiotype vaccines are composed of the entire lymphoma-derived Ig coupled to the immunogenic carrier KLH and are administered subcutaneously with adjuvant. We have developed a idiotype production strategy based on bacterial expression of the lymphoma-derived idiotype as a recombinant Fab fragment (Bertinetti et al., EJH 2006). Intradermal administration of this antigen with lipid-based adjuvant and subcutaneous coadministration of GM-CSF had excellent immunogenicity in a phase I trial of advanced, heavily pretreated B-NHL patients (Bertinetti et al., Cancer Research 2006). In a subsequent phase II trial, 20 patients with untreated indolent B-NHL (14 follicular [FL], 3 nodal marginal zone [nMZL], 3 mantle cell [MCL]) and without immediate need for cytoreduction received at least 6 monthly idiotype vaccinations. No grade IV toxicities were seen, and the sole case of grade III toxicity, generalized erythema, did not preclude completion of the vaccination schedule. Prior to vaccination, 5/19 patients (26%) had decreased CD4+ and 6/19 patients (31%) low CD8+ T cells counts. Furthermore, 10/12 anti-HbS-negative patients (83%) failed to mount a detectable immune response to a conventional hepatitis B vaccine administered concomitantly to idiotype vaccination. Despite this functional immunodeficiency, 12/18 analyzed patients (66%) developed a cellular immune response to idiotype as detected by enumeration of IFNgamma-secreting cells by DC-ELISpot. The ELISpot protocol was validated by blinded interlaboratory testing (www.cimt.de). The frequency of idiotype-responding T cells increased from the 2nd to the 6th vaccination and could be effectively boostered by maintenance immunization in 3-monthly intervals. In vitro stimulation of PBMC from responding patients with idiotype induced specific proliferation of CD4+ T-cells and a shift towards a Th1 response in post-vaccination samples. In addition, 8/18 analyzed patients (44%) developed anti-idiotype IgG or IgM antibodies as assessed by ELISA, and the combined immune response rate was 85%. After a median follow-up of 34 months, 8 patients (40%) are progression-free, and 10 (50%) did not require cytoreductive therapy. Cellular immune responses were associated with superior PFS (p<0.05), and 5 of 6 non-responders eventually required cytoreductive therapy. Humoral immune responses were not related to PFS. Six patients (30%; only FL or nMZL) achieved an objective partial remission, including near-complete disappearance of a large submandibular mass and one subcutaneous lymphoma mass. All objective responders developed specific cellular immunity, but only 4 anti-idiotype antibodies. Five patients are in continuing remission for 12–49 months. Intradermal immunization with the chosen idiotype formulation has excellent immunogenicity despite a severely impaired immune function in untreated B-NHL patients. Furthermore, this is the first active immunotherapy trial showing objective and durable lymphoma responses in first-line therapy at a higher rate than expected for spontaneous remissions. In this setting, and in contrast to conventional idiotype vaccination schedules, cellular anti-idiotype immunity may play a crucial role for a favorable clinical outcome. Since passive humoral anti-lymphoma immunity can be easily transferred by infusions of commercially available monoclonal antibodies, synergistic benefit may be envisioned for an initial vaccination course aimed to prime anti-idiotype T-cells combined with subsequent passive immunotherapy.
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Neelapu, Sattva S., Nikhil C. Munshi, Sundar Jagannath, Thelma M. Watson, Robin Pennington, Bart Barlogie, and Larry W. Kwak. "Tumor Antigen Immunization of Sibling Stem Cell Transplant Donors in Multiple Myeloma." Blood 104, no. 11 (November 16, 2004): 3340. http://dx.doi.org/10.1182/blood.v104.11.3340.3340.
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Abstract Strategies to enhance the specific anti-tumor effect of the graft without increasing the risk of graft-versus-host disease (GVHD) are needed to improve the outcome in allotransplant recipients. In this pilot study, we vaccinated sibling donors against a defined, patient tumor-derived antigen prior to bone marrow harvest. The objective of this strategy was to induce tumor antigen-specific immunity in healthy donors and to transfer this immunity to the recipients by bone marrow transplantation (BMT). For this purpose, the unique antigenic determinants (Idiotype [Id]) of the immunoglobulin secreted by the myeloma tumor can serve as a safe, tumor-specific antigen for active immunotherapy. The vaccine formulation consisted of Id isolated from the plasma of myeloma patients chemically conjugated to a carrier molecule keyhole limpet-hemocyanin (KLH) and administered together with GM-CSF as an adjuvant. Immunization of the HLA-matched sibling donors (n = 5) prior to bone marrow harvest, induced specific cellular and/or humoral immune responses against Id and KLH in all five donors. No short-term or long-term toxicities were observed in any of the donors following vaccination. The recipients received priming vaccination pretransplant and booster immunizations starting approximately 3 months after the myeloablative transplantation. Following BMT, two patients died within 30 days due to transplant related complications. Id-specific and KLH-specific T cell responses were detected in all three surviving patients post-, but not pre-BMT. In at least one patient, Id-specific T cell immunity persisted beyond 18 months after completion of the vaccination schedule. All three surviving patients converted from a partial response to a complete response following BMT. Two of the three patients (both recipients of immune BMT from syngeneic twins) remain in complete remission 8 years and 7 years after the transplant, and the third patient developed chronic steroid-dependent GVHD and died of renal failure after 5.5 years while in complete remission from the disease. Our results suggest that Id vaccination induces specific T cell immunity in the donors that is transferable by BMT, is associated with a prolonged disease-free survival in recipients and may represent a novel strategy to enhance the graft versus myeloma effect. These encouraging results have prompted us to initiate a clinical trial to evaluate this approach of donor immunization in the context of non-myeloablative allogeneic peripheral blood stem cell transplantation in myeloma patients.
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Sika-Paotonu, Dianne, and Urijah Liligeto. "The utility of Benzathine Penicillin G for Rheumatic Fever prevention in the Solomon Islands." Journal of Immunology 202, no. 1_Supplement (May 1, 2019): 229.1. http://dx.doi.org/10.4049/jimmunol.202.supp.229.1.
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Abstract Acute Rheumatic Fever (ARF) frequently affects children and young adults and is an autoimmune condition caused by untreated Group A Streptococcal (GAS) infection of the upper respiratory tract (and skin). Repeated or very severe ARF attacks that are left untreated, can lead to Rheumatic Heart Disease (RHD) - permanent cardiac damage. RHD is rare in developed countries and yet remains a significant cause of morbidity and mortality worldwide. Unfortunately the disease burden of ARF and RHD amongst Indigenous and Pacific communities in New Zealand, Australia and the Pacific Region are amongst the highest in the world. In the absence of a GAS vaccine, the recommended preventative measure for ARF/RHD consists of painful monthly injections of a type of Penicillin known as Benzathine Penicillin G (BPG). Otherwise known as secondary prophylaxis (SP), the purpose of these injections is to prevent GAS infections that can trigger recurrence of ARF and either lead to or worsen RHD. The adherence to SP remains challenging across many settings and it is recognised that a new Penicillin that is more appropriate is needed. To support the drug design efforts and development of a new BPG formulation, this work sought to explore BPG SP for Rheumatic Fever in the Solomon Islands by engaging with health professionals, researchers and community leaders and sourcing local information. Access and other issues connected with BPG SP for those having received a previous diagnosis of ARF were identified. Information concerning these challenges are relevant for drug design efforts and SP schedules for ARF/RHD prevention.
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Tatochenko, V. K. "About immunoprevention vaccine schedule." PULMONOLOGIYA, no. 4 (August 28, 2007): 112–17. http://dx.doi.org/10.18093/0869-0189-2007-0-4-112-117.
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Schmitt, Heinz-J., Gudrun Maechler, Pirmin Habermehl, Markus Knuf, Roland Saenger, Norman Begg, and Dominique Boutriau. "Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine." Clinical and Vaccine Immunology 14, no. 4 (February 7, 2007): 426–34. http://dx.doi.org/10.1128/cvi.00377-06.
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ABSTRACT We evaluated two formulations of a new combined Haemophilus influenzae type b (Hib)-meningococcal serogroup C (MenC)-tetanus toxoid (TT) conjugated vaccine and two formulations of a new MenC-TT vaccine (trials 711202/001 and 711202/008; clinical trial register numbers NCT00135486 and NCT00135564 [www.ClinicalTrials.gov ]). A total of 520 healthy infants were randomized to receive primary vaccination (at 2, 3, and 4 months) with either MenC-TT plus diphtheria-tetanus-acellular pertussis (DTPa)-hepatitis B virus (HBV)-inactivated poliovirus (IPV)/Hib, Hib-MenC-TT plus DTPa-HBV-IPV, or MenC-CRM197 plus DTPa-HBV-IPV/Hib (control). At 12 to 15 months, subjects received a polysaccharide challenge with meningococcal polysaccharide C plus a DTPa-HBV-IPV/Hib booster. Immune responses were assessed 1 month after dose 2, 1 month after dose 3, and prior to and 1 month after the booster. After primary vaccination, there was no difference between groups in seroprotection rates as measured by titers of serum bactericidal antibody (SBA) to MenC (≥1:8) or concentrations of anti-polyribosyl ribitol phosphate (PRP) antibody (≥0.15 μg/ml). Prior to the booster, there was no difference between groups in SBA seroprotection rates, whereas anti-PRP seroprotection rates were significantly higher after priming with Hib-MenC-TT. Booster doses induced large increases in SBA and anti-PRP antibodies in primed groups, indicating successful priming with induction of immune memory. Reactogenicity and safety were similar in all groups during the primary and booster phases. A novel combined Hib-MenC-TT conjugate vaccine induced MenC and Hib responses comparable to those induced by licensed monovalent vaccines. A Hib-MenC-TT conjugate vaccine provides vaccination against two major pathogens in a single injection and is a suitable candidate for use in primary or booster vaccination schedules.
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Cohen, Adam D., Nikoletta Lendvai, Sacha Gnjatic, Achim A. Jungbluth, Stephane Bertolini, Linda Pan, Ralph Venhaus, et al. "Recombinant (rec) MAGE-A3 Protein Immunotherapy and Peripheral Blood Lymphocyte (PBL) Reconstitution Induce Strong Antigen-Specific Humoral and Cellular Immune Responses in Patients Undergoing Autologous Stem Cell Transplantation (ASCT) for Consolidation of Multiple Myeloma (MM)." Blood 124, no. 21 (December 6, 2014): 1184. http://dx.doi.org/10.1182/blood.v124.21.1184.1184.
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Abstract BACKGROUND: MAGE-A3 is an immunogenic tumor-associated antigen detected in 1/3 of newly diagnosed MM patients, and confers a poor prognosis, making it a rational target for immunotherapy. We previously reported (Cohen et al, ASH 2013, #154) that pre- and post-ASCT administration of recMAGE-A3 + AS15 adjuvant (containing MPL, QS21, and CpG7909) and infusion of vaccine-primed autologous peripheral blood lymphocytes (PBL) in the early post-ASCT period had an acceptable safety profile and induced robust antibody responses against MAGE-A3. We now report our initial cellular immune response data, and update the humoral response and clinical outcome data. METHODS: The composition of recMAGE-A3 +AS15 and the immunization schedule (Fig. 1) for this pilot study have been described (ASH 2013, #154). Antibody responses were assessed by ELISA. CD4 and CD8 T cell responses were assessed by ELISpot and intracellular cytokine release assays after in vitro re-stimulation with MAGE-A3 overlapping peptide pools or controls and autologous antigen-presenting cells. Clinical responses were determined by IMWG criteria. M3H67 mAb (specific for MAGE-A3 and homologous MAGE-A family members) was used for assessing expression in MM cells by immunohistochemistry (IHC). RESULTS: Thirteen patients enrolled (med. age 56; 45% high-risk cytogenetics; 42% ISS II/III). All had MAGE-A+ myeloma cells and had achieved at least VGPR following induction. Twelve of 12 (100%) subjects tested to date developed high-titer (1:104-106) antibodies against MAGE-A3 that persisted to at least 1 year post-SCT. These titers were 10-100-fold higher than those seen in a prior study in lung cancer patients with recMAGE-A3 + AS02b, an older adjuvant lacking CpG7909 (PNAS 2008; 105:1650). Epitope mapping identified at least 7 distinct MAGE-A3 epitopes clustering in the hydrophobic regions from aa. 1-100 and 220-300. Isotyping and IgG subclass analysis demonstrated IgG class switching in all patients, with IgG1 and IgG3 subclasses most prevalent. Peripheral blood T cell responses have been evaluated in 3 subjects to date. All had MAGE-A3-specific CD4 responses by IFNγ ELISpot starting as early as d+31 after ASCT, with significant expansion after booster vaccinations and persistence through 1 year post-ASCT. Intracellular cytokine staining confirmed a polyfunctional, Th1-biased CD4 T cell response (IFNγ+, TNFα+, IL5-) in all 3 patients. No CD8 responses against MAGE-A3 have been detected to date. Clinical response assessments were as follows: there were 12 VGPR and 1 CR at enrollment, 7 VGPR and 6 CR (3 stringent CR) at 3 months (mos.) post-ASCT, and 3 VGPR and 5 CR (4 sCR) at 1 year post-ASCT, with 4 patients relapsing at or before 1 year, and 1 not yet evaluable. With a median follow-up of 19 mos. (range 6-32), 6 patients have relapsed (estimated median PFS is 24 mos.) and 1 died of progressive MM. There was no difference between progressors and non-progressors with regard to cytogenetics, baseline MAGE-A expression, antibody titers, hematologic response, or use of lenalidomide maintenance (n=4). MAGE-A expression was assessed by IHC in 3 relapse bone marrow biopsies, and all were negative. CONCLUSIONS: RecMAGE-A3 immunotherapy and PBL reconstitution is well-tolerated, feasible, and induces antibody and Th1-biased CD4 T cell responses, but not CD8 responses, in the setting of ASCT for MM. Cellular immune assessments are ongoing. The magnitudes of antibody and CD4 responses appear greater than those seen historically with older formulations of recMAGE-A3 in other cancers, despite significant immune compromise after ASCT, suggesting a benefit from the new AS15 adjuvant formulation, or from immunization and autologous PBL transfer in the peri-ASCT setting, or both. The loss of MAGE-A3 expression in relapsing patients implies antigen-specific immune selective pressure even in the absence of CD8 T cell responses, and also suggests that combination strategies aimed at limiting immune escape (eg multi-antigen vaccines) should be investigated. Clinical outcomes are promising for this high-risk patient population. These results support advanced phase clinical trials to investigate clinical efficacy of recMAGE-A3 vaccine immunotherapy in MM. Figure 1 Figure 1. Disclosures Cohen: Onyx Pharmaceuticals: Advisory Board, Advisory Board Other; Bristol-Myers Squibb: Advisory Board, Advisory Board Other, Research Funding; Janssen: Advisory Board, Advisory Board Other; Celgene: Member, Independent Response Adjudication Committee Other. Bertolini:Ludwig Institute for Cancer Research: Employment. Pan:Ludwig Institute for Cancer Research: Employment. Venhaus:Ludwig Institute for Cancer Research: Employment. Fellague-Chebra:GlaxoSmithKline: Employment. Gruselle:GlaxoSmithKline: Employment.
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Doshi, Peter, Kyungwan Hong, Tom Jefferson, Mark Jones, and Anisa Rowhani-Farid. "Control vaccine formulation." Lancet 397, no. 10279 (March 2021): 1061–62. http://dx.doi.org/10.1016/s0140-6736(21)00382-2.
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Saah, Alfred J., and Nubia Muñoz. "Control vaccine formulation – Authors' reply." Lancet 397, no. 10279 (March 2021): 1062. http://dx.doi.org/10.1016/s0140-6736(21)00437-2.
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