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Phase II Meningococcal B Vesicle Vaccine Trial in New Zealand Infants
  1. Catherine M Jackson
  1. The University of Auckland, New Zealand
    1. Diana R Lennon (d.lennon{at}auckland.ac.nz)
    1. The University of Auckland, New Zealand
      1. Viliame TK Sotutu
      1. The University of Auckland, New Zealand
        1. Jacqueline Yan
        1. The University of Auckland, New Zealand
          1. Joanna M Stewart
          1. The University of Auckland, New Zealand
            1. Stewart Reid
            1. Ropata Village Medical Centre, New Zealand
              1. Sue Crengle
              1. The University of Auckland, New Zealand
                1. Philipp Oster
                1. Novartis Vaccines, Italy
                  1. Ellen Ypma
                  1. Novartis Vaccines, Italy
                    1. Ingeborg Aaberge
                    1. Norwegian Institute of Public Health, Norway
                      1. Kim Mulholland
                      1. London School of Hygiene and Medicine, United Kingdom
                        1. Diana R Martin
                        1. Institute of Environmental Science and Research, New Zealand

                          Abstract

                          A tailor-made serogroup B outer membrane vesicle vaccine was evaluated in the context of an 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 to 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 six weekly intervals.

                          Main Outcome Measures: Immune response was determined by human complement mediated serum bactericidal assay. Sero-response was a four-fold or greater rise in titre compared to baseline, with baseline titres < 4 required to increase to ≥8. Blood samples were taken pre-vaccination, 6 weeks after dose two, and 4 weeks after dose three. Local and systemic reactions were recorded for 7 days after vaccination.

                          Results: Sero-response to the candidate vaccine strain, NZ98/254, was demonstrated in 74 % (95%CI: 68-80% intention-to-treat; 67-79% 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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