title: New zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months.
abstract: BACKGROUND
  New Zealand has experienced an epidemic of Neisseria meningitidis dominated by strain B:4:P1.7b,4 since 1991. Children younger than 5 years are at highest risk. Previous serogroup B outer membrane vesicle (OMV) strain specific vaccines have shown variable efficacy in this age group.
  
  
  OBJECTIVE
  To evaluate the immunogenicity, reactogenicity and safety in 16-24-month-old children of an OMV vaccine developed against the New Zealand epidemic strain.
  
  
  METHODS
  Children (332) aged 16-24 months were randomized to receive the New Zealand candidate vaccine made using strain NZ98/254 (B:4:P1.7b,4) or the Norwegian parent vaccine made using strain 44/76 (B:15:P1.7,16). Vaccines (25 microg/dose) were administered at 0, 6 and 12 weeks in this observer-blind trial. Immune response was measured by serum bactericidal assay and enzyme-linked immunosorbent assay. Sero-response was defined as a 4-fold or greater rise in serum bactericidal antibody titer compared with baseline, with titers <1:4 required to increase to >or=1:8 to be considered a sero-response. Local and systemic reactions were monitored for 7 days after vaccination.
  
  
  RESULTS
  Sero-response against NZ98/254 was achieved after 3 doses in 75% (95% CI: 69-80%) receiving the New Zealand candidate vaccine by both intention to treat (ITT) and per protocol (PP) analyses. In Norwegian parent vaccinees this was seen in 3% (0-12%) (ITT) and 4% (0-13%) (PP). Vaccines were well tolerated with no vaccine-related serious adverse events.
  
  
  CONCLUSIONS
  The New Zealand candidate vaccine administered to these 16-24-month-old children in 3 doses was safe and elicited a promising immune response against the candidate vaccine strain NZ98/254 (N. meningitidis B:4:P1.7b,4) contributing to vaccine licensure for this age group.
authors.affiliation: The University of Auckland, Auckland, New Zealand.
authors.forename: Sharon
authors.initials: S
authors.lastname: Wong
authors.forename: Diana
authors.initials: D
authors.lastname: Lennon
authors.forename: Catherine
authors.initials: C
authors.lastname: Jackson
authors.forename: Joanna
authors.initials: J
authors.lastname: Stewart
authors.forename: Stewart
authors.initials: S
authors.lastname: Reid
authors.forename: Sue
authors.initials: S
authors.lastname: Crengle
authors.forename: Sandrine
authors.initials: S
authors.lastname: Tilman
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Aaberge
authors.forename: Jane
authors.initials: J
authors.lastname: O'Hallahan
authors.forename: Philipp
authors.initials: P
authors.lastname: Oster
authors.forename: Kim
authors.initials: K
authors.lastname: Mulholland
authors.forename: Diana
authors.initials: D
authors.lastname: Martin
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D001770:Blood Bactericidal Activity; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology; D038541:Neisseria meningitidis, Serogroup B / Q000145:classification / Q000276:immunology*; D009520:New Zealand; D016037:Single-Blind Method; D013045:Species Specificity; D016896:Treatment Outcome
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines