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Clinical and Vaccine Immunology, November 2007, p. 1393-1399, Vol. 14, No. 11
1071-412X/07/$08.00+0     doi:10.1128/CVI.00167-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Immunogenicity, Reactogenicity, and Safety of a P1.7b,4 Strain-Specific Serogroup B Meningococcal Vaccine Given to Preteens{triangledown}

Jamie Hosking,1 Kumanan Rasanathan,1 Florina Chan Mow,1 Catherine Jackson,1 Diana Martin,2 Jane O'Hallahan,3 Philipp Oster,4 Ellen Ypma,4 Stewart Reid,5 Ingeborg Aaberge,6 Sue Crengle,1 Joanna Stewart,1 and Diana Lennon1*

University of Auckland, Auckland, New Zealand,1 Institute of Environmental Science and Research, Porirua, New Zealand,2 Ministry of Health, Wellington, New Zealand,3 Novartis Vaccines S.r.l., Siena, Italy,4 Ropata Village Medical Centre, Lower Hutt, New Zealand,5 Norwegian Institute of Public Health, Oslo, Norway6

Received 18 April 2007/ Returned for modification 29 May 2007/ Accepted 6 August 2007

New Zealand (NZ) has experienced a Neisseria meningitidis serogroup B epidemic since 1991. MeNZB, a strain-specific outer membrane vesicle vaccine made using an NZ epidemic strain isolate, NZ98/254 (B:4:P1.7b,4), from two manufacturing sites, the Norwegian Institute of Public Health (NIPH) and Chiron Vaccines (CV; now Novartis), was evaluated for safety, immunogenicity, and reactogenicity in this observer-blind trial with 8- to 12-year-old children. In year 1, cohort A (n = 302) was randomized 4:1 for receipt of NIPH-MeNZB or MenBvac (Norwegian parent vaccine strain 44/76; B:15:P1.7,16). In year 2, cohort B (n = 313) was randomized 4:1 for receipt of CV-MeNZB or NIPH-MeNZB. Participants all received three vaccinations 6 weeks apart. Local and systemic reactions were monitored for 7 days. Seroresponse was defined as a fourfold or greater rise in the serum bactericidal antibody titer from the baseline titer as measured by a serum bactericidal assay. Those with baseline titers of <1:4 required titers of ≥1:8 to serorespond. Intention-to-treat (ITT) and per protocol (PP) analyses are presented. In cohort A, 74% (ITT) and 73% (PP) of NIPH-MeNZB recipients demonstrated seroresponses against NZ98/254 after three doses, versus 32% (ITT and PP) of MenBvac recipients. In cohort B, seroresponses against NZ98/254 after three doses occurred in 79% (ITT and PP) of CV-MeNZB versus 75% (ITT) and 76% (PP) of NIPH-MeNZB recipients. Vaccines were tolerable, with no vaccine-related serious adverse events. In conclusion, the NZ strain meningococcal B vaccine (MeNZB) from either manufacturing site was immunogenic against New Zealand epidemic vaccine strain meningococci with no safety concerns when given in three doses to these 8- to 12-year-old children.

* Corresponding author. Mailing address: Community Paediatrics, School of Population Health, University of Auckland, Private Bag 92019, Auckland, New Zealand. Phone: 64 9 373 7599. Fax: 64 9 303 5932. E-mail: d.lennon{at}auckland.ac.nz

{triangledown} Published ahead of print on 26 September 2007.

Clinical and Vaccine Immunology, November 2007, p. 1393-1399, Vol. 14, No. 11
1071-412X/07/$08.00+0     doi:10.1128/CVI.00167-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.





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