ORIGINAL ARTICLES

Phase II meningococcal B vesicle vaccine trial in New Zealand infants

C Jackson¹, D R Lennon¹, V T K Sotutu¹, J Yan¹, J M Stewart¹, S Reid², S Crengle¹, P Oster³, E Ypma³, I Aaberge⁴, K Mulholland⁵, D R Martin⁶

¹ The University of Auckland, Auckland, New Zealand
² Ropata Village Medical Centre, Lower Hutt, New Zealand
³ Novartis Vaccines S.r.l., Siena, Italy
⁴ Norwegian Institute of Public Health, Oslo, Norway
⁵ London School of Hygiene and Medicine, London, UK
⁶ Institute of Environmental Science and Research Ltd (ESR), Wellington, New Zealand

^{Correspondence to} Professor Diana Lennon, Community Paediatrics, School of Population Health, The University of Auckland, Private Bag 92019, Auckland, New Zealand; d.lennon{at}auckland.ac.nz

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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