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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| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
American Society for Microbiology
2025-04-01
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| Series: | mSphere |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/msphere.00898-24 |
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| Summary: | 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. |
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| ISSN: | 2379-5042 |