Methods to evaluate serogroup B meningococcal vaccines: From predictions to real-world evidence

Raymond Borrow, Muhamed Kheir Taha, Marzia Monica Giuliani, Mariagrazia Pizza, Angelika Banzhoff, Rafik Bekkat-Berkani*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

10 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)862-872
Number of pages11
JournalJournal of Infection
Volume81
Issue number6
DOIs
Publication statusPublished - Dec 2020

Bibliographical note

Funding Information:
AB, MMG, MP and RBB are employees of the GSK group of companies and hold shares as part of their employee remuneration. MKT reports grants from the GSK group of companies and Pfizer during the conduct of the work; grants from Sanofi, outside the submitted work. In addition, MKT has a patent (NZ630133A) issued with the GSK group of companies. RB has performed contract research on behalf of Public Health England for the GSK group of companies, Pfizer and Sanofi.

Funding Information:
The authors would like to thank Eva Hong and Ala-Eddine Deghmane (Institut Pasteur, National Reference center for Meningococci and Haemophilus influenzae) for their helpful discussion on MATS assay. The authors also thank the Modis platform for writing support, editorial assistance and manuscript coordination, on behalf of GSK. Petronela M. Petrar provided medical writing support and Divya Kesters coordinated the manuscript development and provided editorial support. This work was sponsored by GlaxoSmithKline Biologicals SA, which funded all costs associated with the development and the publishing of the present manuscript.

Publisher Copyright:
© 2020 GlaxoSmithKline Biologicals SA

Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.

Keywords

  • 4CMenB
  • BAST
  • MATS
  • MEASURE
  • MenB-FHbp
  • Meningococcal serogroup B
  • Strain coverage
  • Typing
  • gMATS
  • hSBA

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