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.
From the *The University of Auckland, Auckland, New Zealand, †Ropata Village Medical Centre, Lower Hutt, New Zealand; ‡Novartis Vaccines, Siena, Italy; §New Zealand Ministry of Health, Wellington, New Zealand; ¶London School of Hygiene and Tropical Medicine, London, United Kingdom; and ∥Institute of Environmental Science & Research Ltd (ESR), Wellington, New Zealand.
Accepted for publication November 13, 2008.
The New Zealand Ministry of Health and Novartis Vaccines funded this trial.
Potential conflicts of interest: D. L., S. R. and D. M. received travel funds from the sponsors.
Information in the manuscript was presented at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 2006, San Francisco, CA. (Abstract number G-143.)
Address for correspondence: Diana Lennon, FRACP, Community Paediatrics, School of Population Health, The University of Auckland, Private Bag 92019, Auckland, New Zealand. E-mail: email@example.com.
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