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


Wong, SH; Lennon, DR; Jackson, CM; Stewart, JM; Reid, S; Ypma, E; O'Hallahan, JM; Oster, P; Mulholland, K; Martin, DR; (2009) Immunogenicity and Tolerability in Infants of a New Zealand Epidemic Strain Meningococcal B Outer Membrane Vesicle Vaccine. [Conference or Workshop Item]

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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 McNZB administered with routine New Zealand immunizations at 6 weeks, 3 months, and 5 months of age (n = 375). Group 1 (n = 250) received 25 mu g 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.

Item Type: Conference or Workshop Item
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
Vaccine Centre
PubMed ID: 19384263
Web of Science ID: 265619400005
URI: http://researchonline.lshtm.ac.uk/id/eprint/5341

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