New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months


Wong, S; Lennon, D; Jackson, C; Stewart, J; Reid, S; Crengle, S; Tilman, S; Aaberge, I; O'Hallahan, J; Oster, P; Mulholland, K; Martin, D; (2007) New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months. The Pediatric infectious disease journal, 26 (4). pp. 345-350. ISSN 0891-3668 DOI: 10.1097/01.inf.0000258697.05341.2c

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Abstract

Background: New Zealand has experienced an epidemic of Neisseria meningitidis dominated by strain B:4:P1.7b,4 since 1991. Children younger than 5 years are at highest risk. Previous sero-group B outer membrane vesicle (OMV) strain specific vaccines have shown variable efficacy in this age group. Objective: To evaluate the immunogenicity, reactogenicity and safety in 16-24-month-old children of an OMV vaccine developed against the New Zealand epidemic strain. Methods: Children (332) aged 16-24 months were randomized to receive the New Zealand candidate vaccine made using strain NZ98/254 (B:4:P1.7b,4) or the Norwegian parent vaccine made using strain 44/76 (13:15P1.7,16). Vaccines (25 mu g/dose) were administered at 0, 6 and 12 weeks in this observer-blind trial. Immune response was measured by serum bactericidal assay and enzyme-linked immunosorbent assay. Sero-response was defined as a 4-fold or greater rise in serum bactericidal antibody titer compared with baseline. with titers < 1:4 required to increase to >= 1:8 to be considered a sero-response. Local and systemic reactions were monitored for 7 days after vaccination. Results: Sero-response against NZ98/254 was achieved after 3 doses in 75% (95% CI: 69-80%) receiving the New Zealand candidate vaccine by both intention to treat (ITT) and per protocol (PP) analyses. In Norwegian parent vaccinees this was seen in 3% (0-12%) (ITT) and 4% (0-13%) (PP). Vaccines were well tolerated with no vaccine-related serious adverse events. Conclusion: The New Zealand candidate vaccine administered to these 16-24-month-old children in 3 doses was safe and elicited a promising immune response against the candidate vaccine strain NZ98/254 (N. meningitidis B:4:P1.7b,4) contributing to vaccine licensure for this age group.

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
PubMed ID: 17414400
Web of Science ID: 245287200014
URI: http://researchonline.lshtm.ac.uk/id/eprint/10035

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