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Methods to evaluate serogroup B meningococcal vaccines: From predictions to real-world evidence
Ray Borrow1, Muhamed-Kheir Taha2, Marzia Monica Giuliani3
1Meningococcal Reference Unit, Public Health England, Manchester, United Kingdom.
Abstract:
Serogroup B meningococci (MenB) remain a prominent cause of invasive meningococcal disease (IMD). The protein-based multicomponent 4CMenB and the bivalent MenB-FHbp are the only currently available vaccines against MenB-caused IMD. Efficacy studies are not possible, due to the low incidence of IMD. Therefore, the vaccines' immunogenicity has been evaluated against several target strains chosen to quantify complement-mediated killing induced by each vaccine component in the serum bactericidal antibody assay. However, due to the wide genetic diversity and different expression levels of vaccine antigens across MenB strains, vaccine performance may differ from one strain to another. Here, we review the methods used to predict MenB strain coverage for 4CMenB and MenB-FHbp. Phenotypic assays such as the meningococcal antigen typing system (MATS, 4CMenB-specific) and the flow cytometric meningococcal antigen surface expression assay (MEASURE; MenB-FHbp-specific) were developed. Genomic approaches are also available, such as genetic MATS (gMATS) and the Bexsero antigen sequence type (BAST) scheme, both 4CMenB-specific. All methods allow tentative predictions of coverage across MenB strains, including that afforded by each vaccine antigen, and are rapid and reproducible. Real-world data on vaccine effectiveness are needed to confirm predictions obtained by these methods.
Insights
Predicting the coverage of Serogroup B meningococcal vaccines (MenB) is crucial due to strain diversity. Phenotypic and genomic methods offer rapid predictions, but real-world effectiveness data are needed for confirmation.
Area of Science:
- Vaccinology
- Microbiology
- Immunology
Background:
- Serogroup B meningococci (MenB) are a significant cause of invasive meningococcal disease (IMD).
- Current MenB vaccines, 4CMenB and MenB-FHbp, lack direct efficacy studies due to low IMD incidence.
- Vaccine immunogenicity is assessed via serum bactericidal antibody assays against selected strains, but antigen diversity poses challenges.
Purpose of the Study:
- To review methods for predicting the strain coverage of 4CMenB and MenB-FHbp vaccines.
- To evaluate the utility of phenotypic and genomic approaches in assessing vaccine performance against diverse MenB strains.
Main Methods:
- Review of established phenotypic assays: meningococcal antigen typing system (MATS) for 4CMenB and meningococcal antigen surface expression assay (MEASURE) for MenB-FHbp.
- Review of genomic approaches: genetic MATS (gMATS) and Bexsero antigen sequence type (BAST) scheme, both for 4CMenB.
- Assessment of method speed, reproducibility, and ability to predict coverage across MenB strains.
Main Results:
- Phenotypic and genomic methods provide rapid and reproducible predictions of MenB vaccine strain coverage.
- These methods allow for tentative predictions of coverage afforded by individual vaccine antigens.
- Both 4CMenB and MenB-FHbp vaccines have associated prediction methodologies.
Conclusions:
- Existing methods offer valuable tools for predicting MenB vaccine coverage against diverse strains.
- Further validation with real-world vaccine effectiveness data is essential to confirm these predictions.
- Continued monitoring of MenB strain diversity is important for vaccine strategy.
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