title: Safety and immunogenicity of New Zealand strain meningococcal serogroup B OMV vaccine in healthy adults: beginning of epidemic control.
abstract: As the first step towards control of a strain specific epidemic of meningococcal disease in New Zealand (NZ), this study, an observer-blind, randomised controlled trial in 75 healthy adults, evaluated safety and immunogenicity of two different dosages of a meningococcal group B vaccine administered in a three dose regime. The "tailor-made" outer membrane vesicle (OMV) vaccine (candidate vaccine) developed using a New Zealand meningococcal group B strain (B:4:P1.7b,4) was well tolerated with no vaccine related serious adverse events. Similar local and systemic reactions were observed in those receiving the New Zealand candidate vaccine and the control parent Norwegian vaccine (MenBvac). A four-fold rise in serum bactericidal antibodies (SBAb) against the vaccine strain 4-6 weeks after the third vaccination was achieved in 100% of New Zealand candidate vaccine 2,519 microg participants and in 87% of 50 microg participants. The safety and immunogenicity profile observed in this study of healthy adults enabled studies in children to be initiated using 25 microg dosage.
authors.affiliation: The University of Auckland, Meningococcal B Project, P.O. Box 98847, South Auckland Mail Centre, Auckland, New Zealand.
authors.forename: V
authors.initials: V
authors.lastname: Thornton
authors.forename: D
authors.initials: D
authors.lastname: Lennon
authors.forename: K
authors.initials: K
authors.lastname: Rasanathan
authors.forename: J
authors.initials: J
authors.lastname: O'Hallahan
authors.forename: P
authors.initials: P
authors.lastname: Oster
authors.forename: J
authors.initials: J
authors.lastname: Stewart
authors.forename: S
authors.initials: S
authors.lastname: Tilman
authors.forename: I
authors.initials: I
authors.lastname: Aaberge
authors.forename: B
authors.initials: B
authors.lastname: Feiring
authors.forename: H
authors.initials: H
authors.lastname: Nokleby
authors.forename: E
authors.initials: E
authors.lastname: Rosenqvist
authors.forename: K
authors.initials: K
authors.lastname: White
authors.forename: S
authors.initials: S
authors.lastname: Reid
authors.forename: K
authors.initials: K
authors.lastname: Mulholland
authors.forename: M J
authors.initials: MJ
authors.lastname: Wakefield
authors.forename: D
authors.initials: D
authors.lastname: Martin
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D006805:Human Experimentation; D006801:Humans; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D009520:New Zealand; D016037:Single-Blind Method; D013045:Species Specificity
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines