Phase II meningococcal B vesicle vaccine trial in New Zealand infants

C Jackson1, D R Lennon, V T K Sotutu

  • 1The University of Auckland, Auckland, New Zealand.

Insights

A meningococcal B vaccine developed against the New Zealand epidemic strain was safe and immunogenic in infants. Three doses of the candidate vaccine induced a sero-response in 74% of infants aged 6-8 months.

Area of Science:

  • Immunology
  • Vaccinology
  • Epidemiology

Background:

  • A meningococcal B epidemic in New Zealand was dominated by Neisseria meningitidis strain B:4:P1.7b,4.
  • A tailor-made outer membrane vesicle vaccine was developed against this epidemic strain.

Purpose of the Study:

  • To assess the safety, reactogenicity, and immunogenicity of a meningococcal B vaccine in infants aged 6-8 months.
  • To evaluate a candidate vaccine against the New Zealand epidemic strain (NZ98/254).

Main Methods:

  • An observer-blind, randomized, controlled trial was conducted in 296 healthy infants in Auckland, New Zealand.
  • Infants received three doses of the candidate meningococcal B vaccine or a meningococcal C conjugate vaccine at 6-weekly intervals.
  • Immune response was measured using a human complement-mediated serum bactericidal assay, with sero-response defined as a fourfold or greater rise in titre.

Main Results:

  • Three doses of the candidate meningococcal B vaccine resulted in a sero-response to strain NZ98/254 in 74% of vaccinees.
  • No recipients of the meningococcal C conjugate vaccine showed a sero-response to NZ98/254.
  • Both vaccines were well-tolerated, with no vaccine-related serious adverse events reported.

Conclusions:

  • The New Zealand candidate meningococcal B vaccine demonstrated safety and immunogenicity against the epidemic strain NZ98/254 in infants aged 6-8 months.
  • Three doses of the vaccine were effective in inducing a protective immune response.
Abstract

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