Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine
ABSTRACT Meningococcal serogroup B (MenB) vaccine licensure was based on the assessment of vaccine-induced immune responses by human serum bactericidal antibody (hSBA) assay against a small number of antigen-specific strains complemented by strain coverage predictions. However, the evaluation of vac...
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| Language: | English |
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American Society for Microbiology
2025-04-01
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| Series: | mSphere |
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| Online Access: | https://journals.asm.org/doi/10.1128/msphere.00898-24 |
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| author | Ray Borrow Laura Tomasi Cont Daniela Toneatto Stefania Bambini Shravani Bobde Woo-Yun Sohn Alessia Biolchi Vega Masignani Peter T. Beernink Maria Lattanzi |
| author_facet | Ray Borrow Laura Tomasi Cont Daniela Toneatto Stefania Bambini Shravani Bobde Woo-Yun Sohn Alessia Biolchi Vega Masignani Peter T. Beernink Maria Lattanzi |
| author_sort | Ray Borrow |
| collection | DOAJ |
| description | ABSTRACT Meningococcal serogroup B (MenB) vaccine licensure was based on the assessment of vaccine-induced immune responses by human serum bactericidal antibody (hSBA) assay against a small number of antigen-specific strains complemented by strain coverage predictions. However, the evaluation of vaccine strain coverage is challenging because of genotypic and phenotypic diversity in surface-exposed MenB strain antigens. This narrative review considers the principal methods applied to assess the performance of a multicomponent MenB vaccine at different stages of its development. Traditional hSBA assay against a limited panel of strains is useful at all stages, while predicted strain coverage methods, such as the meningococcal antigen typing system, are used independent of clinical trials. A new method, the endogenous complement hSBA assay, has been developed to evaluate a vaccine’s ability to induce a bactericidal immune response in clinical trials, in conditions that approximate real-world settings through the use of each vaccinee’s serum as a source of complement and by testing against a panel of 110 epidemiologically representative MenB strains. Each assay, therefore, has a different scope during the vaccine’s development and all complement each other, enabling comprehensive evaluation of the performance of multicomponent MenB vaccines, in advance of real-world evidence of vaccine effectiveness and vaccine impact. |
| format | Article |
| id | doaj-art-3aa5c8351dca48dba0d7cb797d087011 |
| institution | OA Journals |
| issn | 2379-5042 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | mSphere |
| spelling | doaj-art-3aa5c8351dca48dba0d7cb797d0870112025-08-20T02:30:00ZengAmerican Society for MicrobiologymSphere2379-50422025-04-0110410.1128/msphere.00898-24Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccineRay Borrow0Laura Tomasi Cont1Daniela Toneatto2Stefania Bambini3Shravani Bobde4Woo-Yun Sohn5Alessia Biolchi6Vega Masignani7Peter T. Beernink8Maria Lattanzi9Meningococcal Reference Unit, UK Health Security Agency, Manchester Royal Infirmary, Manchester, United KingdomGSK, Siena, ItalyGSK, Siena, ItalyGSK, Siena, ItalyGSK, Rockville, Maryland, USAGSK, Rockville, Maryland, USAGSK, Siena, ItalyGSK, Siena, ItalyUniversity of California, San Francisco, California, USAGSK, Siena, ItalyABSTRACT Meningococcal serogroup B (MenB) vaccine licensure was based on the assessment of vaccine-induced immune responses by human serum bactericidal antibody (hSBA) assay against a small number of antigen-specific strains complemented by strain coverage predictions. However, the evaluation of vaccine strain coverage is challenging because of genotypic and phenotypic diversity in surface-exposed MenB strain antigens. This narrative review considers the principal methods applied to assess the performance of a multicomponent MenB vaccine at different stages of its development. Traditional hSBA assay against a limited panel of strains is useful at all stages, while predicted strain coverage methods, such as the meningococcal antigen typing system, are used independent of clinical trials. A new method, the endogenous complement hSBA assay, has been developed to evaluate a vaccine’s ability to induce a bactericidal immune response in clinical trials, in conditions that approximate real-world settings through the use of each vaccinee’s serum as a source of complement and by testing against a panel of 110 epidemiologically representative MenB strains. Each assay, therefore, has a different scope during the vaccine’s development and all complement each other, enabling comprehensive evaluation of the performance of multicomponent MenB vaccines, in advance of real-world evidence of vaccine effectiveness and vaccine impact.https://journals.asm.org/doi/10.1128/msphere.00898-244CMenBinvasive meningococcal diseaseNeisseria meningitidisserum bactericidal antibody assayvaccinevaccine effectiveness |
| spellingShingle | Ray Borrow Laura Tomasi Cont Daniela Toneatto Stefania Bambini Shravani Bobde Woo-Yun Sohn Alessia Biolchi Vega Masignani Peter T. Beernink Maria Lattanzi Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine mSphere 4CMenB invasive meningococcal disease Neisseria meningitidis serum bactericidal antibody assay vaccine vaccine effectiveness |
| title | Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine |
| title_full | Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine |
| title_fullStr | Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine |
| title_full_unstemmed | Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine |
| title_short | Methods to evaluate the performance of a multicomponent meningococcal serogroup B vaccine |
| title_sort | methods to evaluate the performance of a multicomponent meningococcal serogroup b vaccine |
| topic | 4CMenB invasive meningococcal disease Neisseria meningitidis serum bactericidal antibody assay vaccine vaccine effectiveness |
| url | https://journals.asm.org/doi/10.1128/msphere.00898-24 |
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