title: Immunogenicity, reactogenicity, and safety of a P1.7b,4 strain-specific serogroup B meningococcal vaccine given to preteens.
abstract: 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.
authors: University of Auckland, Private Bag 92019, Auckland, New Zealand.
authors: Jamie
authors: J
authors: Hosking
authors: Kumanan
authors: K
authors: Rasanathan
authors: Florina Chan
authors: FC
authors: Mow
authors: Catherine
authors: C
authors: Jackson
authors: Diana
authors: D
authors: Martin
authors: Jane
authors: J
authors: O'Hallahan
authors: Philipp
authors: P
authors: Oster
authors: Ellen
authors: E
authors: Ypma
authors: Stewart
authors: S
authors: Reid
authors: Ingeborg
authors: I
authors: Aaberge
authors: Sue
authors: S
authors: Crengle
authors: Joanna
authors: J
authors: Stewart
authors: Diana
authors: D
authors: Lennon
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D002648:Child; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D008585:Meningitis, Meningococcal / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D009520:New Zealand
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines