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Articles de revues sur le sujet "BEXERO VACCINE"
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Wallenfels, Jiří. « News on vaccines against meningococcal disease. Vaccine Bexsero ». Hygiena 64, no 2 (13 juin 2019) : 85. http://dx.doi.org/10.21101/hygiena.b0034.
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Semchenko, Evgeny A., Aimee Tan, Ray Borrow et Kate L. Seib. « The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria gonorrhoeae ». Clinical Infectious Diseases 69, no 7 (14 décembre 2018) : 1101–11. http://dx.doi.org/10.1093/cid/ciy1061.
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Abstract Background Neisseria gonorrhoeae and Neisseria meningitidis are closely-related bacteria that cause a significant global burden of disease. Control of gonorrhoea is becoming increasingly difficult, due to widespread antibiotic resistance. While vaccines are routinely used for N. meningitidis, no vaccine is available for N. gonorrhoeae. Recently, the outer membrane vesicle (OMV) meningococcal B vaccine, MeNZB, was reported to be associated with reduced rates of gonorrhoea following a mass vaccination campaign in New Zealand. To probe the basis for this protection, we assessed the cross-reactivity to N. gonorrhoeae of serum raised to the meningococcal vaccine Bexsero, which contains the MeNZB OMV component plus 3 recombinant antigens (Neisseria adhesin A, factor H binding protein [fHbp]-GNA2091, and Neisserial heparin binding antigen [NHBA]-GNA1030). Methods A bioinformatic analysis was performed to assess the similarity of MeNZB OMV and Bexsero antigens to gonococcal proteins. Rabbits were immunized with the OMV component or the 3 recombinant antigens of Bexsero, and Western blots and enzyme-linked immunosorbent assays were used to assess the generation of antibodies recognizing N. gonorrhoeae. Serum from humans immunized with Bexsero was investigated to assess the nature of the anti-gonococcal response. Results There is a high level of sequence identity between MeNZB OMV and Bexsero OMV antigens, and between the antigens and gonococcal proteins. NHBA is the only Bexsero recombinant antigen that is conserved and surfaced exposed in N. gonorrhoeae. Bexsero induces antibodies in humans that recognize gonococcal proteins. Conclusions The anti-gonococcal antibodies induced by MeNZB-like OMV proteins could explain the previously-seen decrease in gonorrhoea following MeNZB vaccination. The high level of human anti-gonococcal NHBA antibodies generated by Bexsero vaccination may provide additional cross-protection against gonorrhoea.
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Lakos, András, Péter Torzsa et Tamás Ferenci. « Bexsero, egy új, meningococcus elleni vakcina ». Orvosi Hetilap 157, no 7 (février 2016) : 242–46. http://dx.doi.org/10.1556/650.2016.30333.
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Meningococcus B is the most prevalent Neisseria meningitidis serogroup isolated in Hungary. Bexsero is one of the vaccines developed against it, which has been available in Hungary since the summer of 2014. The authors summarize the most important issues and open questions concerning the disease and the vaccine based on literature review. Based on immunological evidence, it is expected that Bexsero provides protection against this rare but very serious infection. However, the vaccine is extremely expensive, the clinical effectiveness has not yet been proven and it frequently causes fever, especially in infants where the vaccine is most needed. According to the opinion of the authors, the formulation of a Hungarian guideline concerning the application of Bexsero should be postponed until the accumulating international experience makes it possible to better judge the vaccine’s benefits, risks and cost-effectiveness. For patients with asplenia, complement defect or other immunological defect, or in case of markedly increased individual risk of contracting the disease, the vaccination is already justified. Orv. Hetil., 2016, 157(7), 242–246.
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Koroleva, I. S., et M. A. Koroleva. « World Experience in the Use Serogroup B Meningococcal Vaccines (literature review) ». Epidemiology and Vaccinal Prevention 20, no 6 (6 janvier 2022) : 100–107. http://dx.doi.org/10.31631/2073-3046-2021-20-6-100-107.
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Relevance. The success of vaccine prophylaxis of meningococcal infection depends on the composition and properties of vaccine preparations and the strict implementation of recommendations on vaccine prophylaxis tactics by the territorial epidemiological characteristics of meningococcal infection. Despite the high burden of B-meningococcal infection, especially among young children, the design of B-meningococcal vaccines has faced serious difficulties. Aim. The literature review presents the history of the development of B-meningococcal vaccines and provides characteristics of two immunologically effective and safe new generation B-meningococcal vaccine preparations. Conclusion. The licensing of the two new B-meningococcal vaccines presented in the review (Bexsero and Trumenba) was based on immunogenicity and safety. The inclusion of vaccines in national vaccination programs requires careful analysis, including analysis of the antigenic characteristics of circulating strains.
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Rodrigues, Charlene M. C., Hannah Chan, Caroline Vipond, Keith Jolley, Odile B. Harrison, Jun Wheeler, Gail Whiting, Ian M. Feavers et Martin C. J. Maiden. « Typing complex meningococcal vaccines to understand diversity and population structure of key vaccine antigens ». Wellcome Open Research 3 (29 novembre 2018) : 151. http://dx.doi.org/10.12688/wellcomeopenres.14859.1.
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Background:Protein-conjugate capsular polysaccharide vaccines can potentially control invasive meningococcal disease (IMD) caused by five (A, C, W, X, Y) of the six IMD-associated serogroups. Concerns raised by immunological similarity of the serogroup B capsule, to human neural cell carbohydrates, has meant that ‘serogroup B substitute’ vaccines target more variable subcapsular protein antigens. A successful approach using outer membrane vesicles (OMVs) as major vaccine components had limited strain coverage. In 4CMenB (Bexsero®), recombinant proteins have been added to ameliorate this problem. Methods:Here, scalable, portable, genomic techniques were used to investigate the Bexsero®OMV protein diversity in meningococcal populations. Shotgun proteomics identified 461 proteins in the OMV, defining a complex proteome. Amino acid sequences for the 24 proteins most likely to be involved in cross-protective immune responses were catalogued within thePubMLST.org/neisseriadatabase using a novel OMV peptide Typing (OMVT) scheme.Results:Among these proteins there was variation in the extent of diversity and association with meningococcal lineages, identified as clonal complexes (ccs), ranging from the most conserved peptides (FbpA, NEISp0578, and putative periplasmic protein, NEISp1063) to the most diverse (TbpA, NEISp1690). There were 1752 unique OMVTs identified amongst 2492/3506 isolates examined by whole-genome sequencing (WGS). These OMVTs were grouped into clusters (sharing ≥18 identical OMVT peptides), with 45.3% of isolates assigned to one of 27 OMVT clusters. OMVTs and OMVT clusters were strongly associated with cc, genogroup, and Bexsero®antigen variants, demonstrating that combinations of OMV proteins exist in discrete, non-overlapping combinations associated with genogroup and Bexsero®Antigen Sequence Type. This highly structured population of IMD-associated meningococci is consistent with strain structure models invoking host immune selection.Conclusions:The OMVT scheme facilitates region-specific WGS investigation of meningococcal diversity and is an open-access, portable tool with applications for vaccine development, especially in the choice of antigen combinations, assessment and implementation.
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Rodrigues, Charlene M. C., Hannah Chan, Caroline Vipond, Keith Jolley, Odile B. Harrison, Jun Wheeler, Gail Whiting, Ian M. Feavers et Martin C. J. Maiden. « Typing complex meningococcal vaccines to understand diversity and population structure of key vaccine antigens ». Wellcome Open Research 3 (19 mars 2019) : 151. http://dx.doi.org/10.12688/wellcomeopenres.14859.2.
Texte intégralRésumé :
Background:Protein-conjugate capsular polysaccharide vaccines can potentially control invasive meningococcal disease (IMD) caused by five (A, C, W, X, Y) of the six IMD-associated serogroups. Concerns raised by immunological similarity of the serogroup B capsule to human neural cell carbohydrates, meant that ‘serogroup B substitute’ vaccines target more variable subcapsular protein antigens. A successful approach using outer membrane vesicles (OMVs) as major vaccine components had limited strain coverage. In 4CMenB (Bexsero®), recombinant proteins have been added to ameliorate this problem. Methods: Scalable, portable, genomic techniques were used to investigate the Bexsero®OMV protein diversity in meningococcal populations. Shotgun proteomics identified 461 proteins in the OMV, defining a complex proteome. Amino acid sequences for the 24 proteins most likely to be involved in cross-protective immune responses were catalogued within thePubMLST.org/neisseriadatabase using a novel OMV peptide Typing (OMVT) scheme.Results:Among these proteins there was variation in the extent of diversity and association with meningococcal lineages, identified as clonal complexes (ccs), ranging from the most conserved peptides (FbpA, NEISp0578, and putative periplasmic protein, NEISp1063) to the most diverse (TbpA, NEISp1690). There were 1752 unique OMVTs identified amongst 2492/3506 isolates examined by whole-genome sequencing (WGS). These OMVTs were grouped into clusters (sharing ≥18 identical OMVT peptides), with 45.3% of isolates assigned to one of 27 OMVT clusters. OMVTs and OMVT clusters were strongly associated with cc, genogroup, and Bexsero®antigen variants, demonstrating that combinations of OMV proteins exist in discrete, non-overlapping combinations associated with genogroup and Bexsero®Antigen Sequence Type. This highly structured population of IMD-associated meningococci is consistent with strain structure models invoking host immune and/or metabolic selection.Conclusions:The OMVT scheme facilitates region-specific WGS investigation of meningococcal diversity and is an open-access, portable tool with applications for vaccine development, especially in the choice of antigen combinations, assessment and implementation.
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Rodrigues, Charlene M. C., Keith A. Jolley, Andrew Smith, J. Claire Cameron, Ian M. Feavers et Martin C. J. Maiden. « Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) Index : a Rapid and Accessible Tool That Exploits Genomic Data in Public Health and Clinical Microbiology Applications ». Journal of Clinical Microbiology 59, no 1 (14 octobre 2020) : e02161-20. http://dx.doi.org/10.1128/jcm.02161-20.
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ABSTRACTAs microbial genomics makes increasingly important contributions to clinical and public health microbiology, the interpretation of whole-genome sequence data by nonspecialists becomes essential. In the absence of capsule-based vaccines, two protein-based vaccines have been used for the prevention of invasive serogroup B meningococcal disease (IMD) since their licensure in 2013 and 2014. These vaccines have different components and different levels of coverage of meningococcal variants. Hence, decisions regarding which vaccine to use in managing serogroup B IMD outbreaks require information about the index case isolate, including (i) the presence of particular vaccine antigen variants, (ii) the expression of vaccine antigens, and (iii) the likely susceptibility of its antigen variants to antibody-dependent bactericidal killing. To obtain this information requires a multitude of laboratory assays, impractical in real-time clinical settings, where the information is most urgently needed. To facilitate assessment for public health and clinical purposes, we synthesized genomic and experimental data from published sources to develop and implement the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) Index, which is publicly available on PubMLST (https://pubmlst.org). Using whole-genome sequences or individual gene sequences obtained from IMD isolates or clinical specimens, the MenDeVAR Index provides rapid evidence-based information on the presence and possible immunological cross-reactivity of different meningococcal vaccine antigen variants. The MenDeVAR Index enables practitioners who are not genomics specialists to assess the likely reactivity of vaccines for individual cases, outbreak management, or the assessment of public health vaccine programs. The MenDeVAR Index has been developed in consultation with, but independently of, both the 4CMenB (Bexsero; GSK) and rLP2086 (Trumenba; Pfizer, Inc.) vaccine manufacturers.
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Maritan, Martina, Roberta Cozzi, Paola Lo Surdo, Daniele Veggi, Matthew James Bottomley et Enrico Malito. « Crystal structures of human Fabs targeting the Bexsero meningococcal vaccine antigen NHBA ». Acta Crystallographica Section F Structural Biology Communications 73, no 6 (11 mai 2017) : 305–14. http://dx.doi.org/10.1107/s2053230x17006021.
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Neisserial heparin-binding antigen (NHBA) is a surface-exposed lipoprotein fromNeisseria meningitidisand is a component of the meningococcus B vaccine Bexsero. As part of a study to characterize the three-dimensional structure of NHBA and the molecular basis of the human immune response to Bexsero, the crystal structures of two fragment antigen-binding domains (Fabs) isolated from human monoclonal antibodies targeting NHBA were determined. Through a high-resolution analysis of the organization and the amino-acid composition of the CDRs, these structures provide broad insights into the NHBA epitopes recognized by the human immune system. As expected, these Fabs also show remarkable structural conservation, as shown by a structural comparison of 15 structures of apo Fab 10C3 which were obtained from crystals grown in different crystallization conditions and were solved while searching for a complex with a bound NHBA fragment or epitope peptide. This study also provides indirect evidence for the intrinsically disordered nature of two N-terminal regions of NHBA.
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Peterson, James, Carmen Deseda, Katie Julien, Betzana Zambrano, Germán Áñez, Sue Jiayuan, Judy Pan et al. « 03. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster Dose in Adults and Adolescents Vaccinated Against Meningococcal Disease 3 - 6 Years Earlier ». Open Forum Infectious Diseases 8, Supplement_1 (1 novembre 2021) : S125. http://dx.doi.org/10.1093/ofid/ofab466.206.
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Abstract Background Booster doses of meningococcal conjugate vaccines may induce long-term protection against invasive meningococcal disease. MenACYW-TT [MenQuadfi®] is a quadrivalent meningococcal conjugate vaccine, licensed for use in ages 2 years and older in USA. The vaccine is also licensed in ages 12 months and older in EU and other countries. Methods A phase IIIb study (NCT04084769) was conducted to evaluate the persistence of immune response in adults and adolescents primed 3-6 years earlier with either MenACYW-TT or MCV4-CRM (Menveo®) and, safety and immunogenicity of MenACYW-TT when administered as a booster dose with or without concomitant administration with MenB vaccines (Bexsero® and Trumenba®). Serum bactericidal assays with human complement (hSBA) and baby rabbit complement (rSBA) were used to measure antibodies against vaccine serogroups at baseline (Day 0 [D0]), D06 (in a subset) and 30 days post-vaccination (D30). Safety data were collected up to 6 months post-vaccination. Results At D0, the GMTs were higher in subjects primed with MenACYW-TT vs MCV4-CRM for serogroups C, Y and W, and were comparable for serogroup A. At D0, all hSBA GMTs were higher than those observed pre-priming dose, suggesting persistence of immunity. Sufficiency of hSBA seroresponse ( >75%) was demonstrated following administration of MenACYW-TT booster dose regardless of the priming vaccine administered 3-6 years earlier. Vaccine seroresponse in a subset of participants at D06 ranged from 77.8% (95%CI 62.9%; 88.8%) for serogroup A to 97.8% (88.5%; 99.9%) for serogroup W suggesting a quick onset of immune response post-booster. Post-vaccination (D30) hSBA GMTs were comparable for serogroups A, Y and W regardless of the nature of the priming vaccine and were higher for serogroup C in subjects primed with MenACYW-TT vaccine. The MenACYW-TT booster dose was well-tolerated and had similar safety profiles regardless of the priming vaccine. The safety profiles were comparable regardless of the MenB vaccine co-administered with MenACYW-TT vaccine. Conclusion MenACYW-TT used as priming vaccine was able to demonstrate persistence of immune response 3-6 years later. MenACYW-TT elicits robust booster responses in adults and adolescents primed with MenACYW-TT or MCV4-CRM Disclosures Betzana Zambrano, MD, Sanofi Pasteur (Employee) Germán Áñez, MD, Sanofi Pasteur (Other Financial or Material Support, Former employee) Sue Jiayuan, MSc, Sanofi Pasteur (Independent Contractor) Judy Pan, PhD, Sanofi Pasteur (Employee) Habiba Arroum, MD, Sanofi Pasteur (Employee) Kucku Varghese, PhD, Sanofi Pasteur (Employee) Emilia Jordanov, MD, Sanofi Pasteur (Employee, Shareholder) Mandeep S. Dhingra, MD, Sanofi Pasteur (Employee, Shareholder)
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Carr, Jeremy, Emma Plested, Parvinder Aley, Susana Camara, Kimberly Davis, Jenny M. MacLennan, Steve Gray et al. « ‘Be on the TEAM’ Study (Teenagers Against Meningitis) : protocol for a controlled clinical trial evaluating the impact of 4CMenB or MenB-fHbp vaccination on the pharyngeal carriage of meningococci in adolescents ». BMJ Open 10, no 10 (octobre 2020) : e037358. http://dx.doi.org/10.1136/bmjopen-2020-037358.
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IntroductionCapsular group B Neisseria meningitidis (MenB) is the most common cause of invasive meningococcal disease (IMD) in many parts of the world. A MenB vaccine directed against the polysaccharide capsule remains elusive due to poor immunogenicity and safety concerns. The vaccines licensed for the prevention of MenB disease, 4CMenB (Bexsero) and MenB-fHbp (Trumenba), are serogroup B ‘substitute’ vaccines, comprised of subcapsular proteins and are designed to provide protection against most MenB disease-causing strains. In many high-income countries, such as the UK, adolescents are at increased risk of IMD and have the highest rates of meningococcal carriage. Beginning in the late 1990s, immunisation of this age group with the meningococcal group C conjugate vaccine reduced asymptomatic carriage and disrupted transmission of this organism, resulting in lower group C IMD incidence across all age groups. Whether vaccinating teenagers with the novel ‘MenB’ protein-based vaccines will prevent acquisition or reduce duration of carriage and generate herd protection was unknown at the time of vaccine introduction and could not be inferred from the effects of the conjugate vaccines. 4CMenB and MenB-fHbp may also impact on non-MenB disease-causing capsular groups as well as commensal Neisseria spp. This study will evaluate the impact of vaccination with 4CMenB or MenB-fHbp on oropharyngeal carriage of pathogenic meningococci in teenagers, and consequently the potential for these vaccines to provide broad community protection against MenB disease.Methods and analysisThe ‘Be on the TEAM’ (Teenagers Against Meningitis) Study is a pragmatic, partially randomised controlled trial of 24 000 students aged 16–19 years in their penultimate year of secondary school across the UK with regional allocation to a 0+6 month schedule of 4CMenB or MenB-fHbp or to a control group. Culture-confirmed oropharyngeal carriage will be assessed at baseline and at 12 months, following which the control group will be eligible for 4CMenB vaccination. The primary outcome is the carriage prevalence of potentially pathogenic meningococci (defined as those with genogroups B, C, W, Y or X), in each vaccine group compared separately to the control group at 12 months post-enrolment, that is, 12 months after the first vaccine dose and 6 months after the second vaccine dose. Secondary outcomes include impact on carriage of: genogroup B meningococci; hyperinvasive meningococci; all meningococci; those meningococci expressing vaccine antigens and; other Neisseria spp. A sample size of 8000 in each arm will provide 80% power to detect a 30% reduction in meningococcal carriage, assuming genogroup B, C, W, Y or X meningococci carriage of 3.43%, a design effect of 1.5, a retention rate of 80% and a significance level of 0.05. Study results will be available in 2021 and will inform the UK and international immunisation policy and future vaccine development.Ethics and disseminationThis study is approved by the National Health Service South Central Research Ethics Committee (18/SC/0055); the UK Health Research Authority (IRAS ID 239091) and the UK Medicines and Healthcare products Regulatory Agency. Publications arising from this study will be submitted to peer-reviewed journals. Study results will be disseminated in public forums, online, presented at local and international conferences and made available to the participating schools.Trial registration numbersISRCTN75858406; Pre-results, EudraCT 2017-004609-42.
Thèses sur le sujet "BEXERO VACCINE"
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BIANCHI, FEDERICA, LUCIA BANCI, CLAUDIO LUCHINAT, DOMENICO MAIONE, ROBERTA COZZI et LAURA SANTINI. « Characterization of the human immune response after vaccination with Bexsero through structural and functional studies of human Fabs from a longitudinal memory B-cell repertoire ». Doctoral thesis, 2018. http://hdl.handle.net/2158/1142497.
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The multi-component vaccine 4CMenB (Bexsero) is the first recombinant vaccine for the prevention of invasive meningococcal disease licensed in over 35 countries. The meningococcal factor H binding protein (fHbp), one of three main protein antigens in 4CMenB, specifically binds human factor H (hfH) and thereby down-regulates the human complement cascade. Over 1000 distinct amino acid sequences of fHbp have been identified and can be classified in three variants which are immunologically distinct. Within the fHbp variant groups the sequence identity is usually above 87%, while between variant groups the sequence identity can be as low as 62%. This high antigenic variability presumably underlies the apparent rarity of cross-reactive antibodies.
We cloned and expressed a library of 110 anti-fHbp human monoclonal antibodies as Fabs (huFab), isolated from adults immunized with 4CMenB. We analyzed their antigen binding specificity and affinity, and their ability to inhibit binding of hfH to live meningococci. Interestingly, although 4CMenB vaccine contains only fHbp variant 1.1, thirteen of the 110 huFabs were found to be cross-reactive for fHbp variants 2 and 3.
All 13 cross-reactive mAbs showed to be able to kill the bacterium when tested in a serum bactericidal assay using baby rabbit serum as complement source (rSBA); only those 3 mAbs competing with hfH binding showed bactericidial activity also with human complement (hSBA). The crystal structure of the fHbp/huFab 4B3 complex was determined and the identification of key antigen/antibody interactions was performed by structural analyses, obtaining atomic insights into the epitope recognized by this huFab. A detailed analysis of the interface revealed high conservation of key epitope residues some of which lie within the hFH binding site, which explains both the ability of huFab 4B3 to cross-react with different fHbp variants and its ability to inhibit hfH binding, thus explaining its unparalleled potency.
In conclusion, we have obtained the first detailed characterization of cross-protective huMabs elicited by 4CMenB and in particular we gained structural data on huFab 4B3, which is able to compete for hFh binding to fHbp. These structural and functional data suggest that the hfH binding site on fHbp can be accessible to the human immune system upon immunization, enabling the generation of a highly potent antibody response
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Luca, Nompari. « Designing Quality : Quality by Design in the analytical pharmaceutical development ». Doctoral thesis, 2018. http://hdl.handle.net/2158/1116278.
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The present thesis study describes an integrated approach for the implementation of Quality by Design principles to screening and development of analytical methods applied to vaccines physical-chemical testing, according to Analytical QbD (AQbD) published in literature.
The research study is focused on application of the risk assessment and the experimental design tools to be used to build knowledge about the analytical methods performance and to mitigate the risks of failure. Risk management tools and mathematical/statistical models have been applied to study and define well characterized analytical methods (based on understanding of method parameters-performance relationships), in order to establish an analytical procedure able to ensure the desired performance and to identify the method design space. The AQbD structured approach clearly mitigates the risk of failure and provides advantages in a life-cycle management prospective.