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Published on: July 31, 2021
Phase II meningococcal B vesicle vaccine trial in New Zealand infants
C Jackson1, D R Lennon, V T K Sotutu
1The University of Auckland, Auckland, New Zealand.
Insights
A meningococcal B vaccine developed against the New Zealand epidemic strain was safe and immunogenic in infants. Three doses of the candidate vaccine induced a sero-response in 74% of infants aged 6-8 months.
Area of Science:
- Immunology
- Vaccinology
- Epidemiology
Background:
- A meningococcal B epidemic in New Zealand was dominated by Neisseria meningitidis strain B:4:P1.7b,4.
- A tailor-made outer membrane vesicle vaccine was developed against this epidemic strain.
Purpose of the Study:
- To assess the safety, reactogenicity, and immunogenicity of a meningococcal B vaccine in infants aged 6-8 months.
- To evaluate a candidate vaccine against the New Zealand epidemic strain (NZ98/254).
Main Methods:
- An observer-blind, randomized, controlled trial was conducted in 296 healthy infants in Auckland, New Zealand.
- Infants received three doses of the candidate meningococcal B vaccine or a meningococcal C conjugate vaccine at 6-weekly intervals.
- Immune response was measured using a human complement-mediated serum bactericidal assay, with sero-response defined as a fourfold or greater rise in titre.
Main Results:
- Three doses of the candidate meningococcal B vaccine resulted in a sero-response to strain NZ98/254 in 74% of vaccinees.
- No recipients of the meningococcal C conjugate vaccine showed a sero-response to NZ98/254.
- Both vaccines were well-tolerated, with no vaccine-related serious adverse events reported.
Conclusions:
- The New Zealand candidate meningococcal B vaccine demonstrated safety and immunogenicity against the epidemic strain NZ98/254 in infants aged 6-8 months.
- Three doses of the vaccine were effective in inducing a protective immune response.
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 >or=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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