Background: A tailor-made serogroup B outer membrane vesicle vaccine was evaluated in the context of a serogroup B meningococcal epidemic dominated by Neisseria meningitidis strain B:4:P1.7b,4.
Objective: To determine the safety, reactogenicity and immunogenicity in infants aged 6–8 months of a meningococcal B vaccine developed against the New Zealand epidemic strain.
Design, setting and participants: Observer-blind, randomised, controlled trial conducted in 296 healthy infants in Auckland, New Zealand.
Intervention: Infants were randomised 4:1 to receive three doses of New Zealand candidate vaccine (epidemic strain NZ98/254, B:4:P1.7b,4) or meningococcal C conjugate vaccine at 6-weekly intervals.
Main outcome measures: Immune response was determined by human complement mediated serum bactericidal assay. Sero-response was a fourfold or greater rise in titre compared to baseline, with baseline titres <4 required to increase to ⩾8. Blood samples were taken before vaccination, 6 weeks after dose two, and 4 weeks after dose three. Local and systemic reactions were recorded for 7 days following vaccination.
Results: Sero-response to the candidate vaccine strain, NZ98/254, was demonstrated in 74% of vaccinees (95% CI: 68% to 80% intention-to-treat; 67% to 79% per protocol) after three doses of New Zealand candidate vaccine. No meningococcal C conjugate vaccine recipients were sero-responders to NZ98/254 after three doses. Both vaccines were well tolerated with no vaccine related serious adverse events.
Conclusions: Our data indicate that the New Zealand candidate vaccine administered in three doses to this group of 6–8-month-old infants was safe and immunogenic against the candidate vaccine strain NZ98/254 (Neisseria meningitidis B:4:P1.7b,4).
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Funding This trial was funded by the New Zealand Ministry of Health and Novartis Vaccines.
Competing interests Diana Lennon received funding for travel from Novartis Vaccines. Philipp Oster and Ellen Ypma are employed by Novartis Vaccines.
Ethics approval The Auckland Ethics Committee approved this trial.
Patient consent Parental consent obtained.
Contributors Professor Diana Lennon, as principal investigator, had access to the data presented in this paper, and takes responsibility for the integrity of the data and the accuracy of the data analysis presented here. Trial concept and design: Lennon, Stewart, Reid, Martin, Mulholland, Crengle, Oster, Sotutu and Aaberge. Acquisition of data: Sotutu, Yan, Jackson, Lennon, Martin and Oster. Analysis and interpretation of data: Stewart, Lennon, Jackson, Sotutu and Martin. Drafting of the manuscript: Jackson, Lennon, Sotutu and Stewart. Critical revision of the manuscript for important intellectual content: Lennon, Jackson, Sotutu, Stewart, Reid, Martin, Mulholland, Crengle, Aaberge and Oster. Statistical analysis: Stewart, Jackson and Ypma. Administrative, technical or material support: Oster and Martin. Trial supervision: Lennon, Oster and Martin.