A review of complement sources used in serum bactericidal assays for evaluating immune responses to meningococcal ACWY conjugate vaccines

Jamie Findlow*, Paul Balmer, Raymond Borrow

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

20 Citations (Scopus)

Abstract

Invasive meningococcal disease is rare and potentially devastating but often vaccine-preventable. Evaluation of meningococcal vaccine effectiveness is impractical owing to relatively low disease incidence; protection is therefore estimated using serum bactericidal antibody (SBA) assays. Original experiments on natural immunity established a titer of ≥4 as the correlate of protection for SBA assays using human complement (hSBA), but human complement is relatively difficult to obtain and standardize. Use of baby rabbit complement (rSBA assays), per standard guidelines for serogroups A and C, generally results in comparatively higher titers. Postlicensure effectiveness data for serogroup C conjugate vaccines support acceptance of rSBA titers ≥8 as the correlate of protection for this serogroup, but no thresholds have been formally established for serogroups A, W, and Y. Studies evaluating MenACWY-TT (Nimenrix®; Pfizer Inc, Sandwich, UK) immunogenicity have used both hSBA and rSBA assays, and ultimately suggest that rSBA may be more appropriate for these measurements.

Original languageEnglish
Pages (from-to)2491-2500
Number of pages10
JournalHuman Vaccines and Immunotherapeutics
Volume15
Issue number10
DOIs
Publication statusPublished - 3 Oct 2019

Bibliographical note

Funding Information:
Medical writing support was provided by Judith Kandel, PhD, of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group Company, and was funded by Pfizer Inc.

Publisher Copyright:
© 2019, © 2019 Pfizer Inc. Published with license by Taylor & Francis Group, LLC.

Keywords

  • MenACWY-TT
  • Meningococcal vaccine
  • Neisseria meningitidis
  • complement
  • immunogenicity
  • serum bactericidal antibody assay

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