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Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e318195205e
Original Article

Immunogenicity and Tolerability in Infants of a New Zealand Epidemic Strain Meningococcal B Outer Membrane Vesicle Vaccine

Wong, Sharon H. FRACP*; Lennon, Diana R. FRACP*; Jackson, Catherine M. MBChB*; Stewart, Joanna M. MSc*; Reid, Stewart FRNZCGP†§; Ypma, Ellen MSc‡; O'Hallahan, Jane M. FAFPHM§; Oster, Philipp MD‡; Mulholland, Kim FRACP¶; Martin, Diana R. PhD∥

Supplemental Author Material
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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 μg 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 ≥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.

© 2009 Lippincott Williams & Wilkins, Inc.

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