Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine

Pediatr Infect Dis J. 2009 May;28(5):385-90. doi: 10.1097/INF.0b013e318195205e.

Abstract

Background: An outer membrane vesicle meningococcal vaccine (MeNZB), was developed for the New Zealand epidemic strain of Neisseria meningitidis B:4:P1.7-2,4.

Methods: A phase II, randomized, observer blind, controlled study evaluating the safety, reactogenicity, and immunogenicity of MeNZB administered with routine New Zealand immunizations at 6 weeks, 3 months, and 5 months of age (n = 375). Group 1 (n = 250) received 25 mug MeNZB and routine immunizations with a fourth MeNZB dose given at 10 months (n = 51). Group 2 (n = 125) received routine immunizations only. Sero-response was a > or =4-fold rise in vaccine strain serum bactericidal antibody titer compared with baseline or a titer of at least 1:8 for baselines <1:4. Reactogenicity was monitored for 7 days after vaccination.

Results: Sero-response in Group 1 was achieved in 53% (95% Confidence interval [CI]: 46-59, n = 239) and 69% (95% CI: 54-80, n = 45) with geometric mean antibody titers of 9 (95% CI: 7-10) and 22 (95% CI: 12-39) after the third and fourth doses, respectively. No negative interference by MeNZB on routine immunizations was detected. There were no serious adverse events judged to be vaccine related.

Conclusions: In this group of New Zealand infants, 4 MeNZB doses were required to demonstrate titers comparable with those achieved after 3 doses in older children. MeNZB was safe when used concomitantly with routine New Zealand immunizations to 5 months of age.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Bacterial Outer Membrane Proteins / immunology*
  • Drug Administration Schedule
  • Female
  • Humans
  • Immunization Schedule
  • Infant
  • Male
  • Meningitis, Meningococcal / blood
  • Meningitis, Meningococcal / epidemiology
  • Meningitis, Meningococcal / immunology
  • Meningitis, Meningococcal / prevention & control*
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / immunology
  • Neisseria meningitidis, Serogroup B / immunology*
  • New Zealand / epidemiology
  • Single-Blind Method

Substances

  • Antibodies, Bacterial
  • Bacterial Outer Membrane Proteins
  • Meningococcal Vaccines