title: Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine.
abstract: BACKGROUND
  An outer membrane vesicle meningococcal vaccine (MeNZB), was developed for the New Zealand epidemic strain of Neisseria meningitidis B:4:P1.7-2,4.
  
  
  METHODS
  A phase II, randomized, observer blind, controlled study evaluating the safety, reactogenicity, and immunogenicity of MeNZB administered with routine New Zealand immunizations at 6 weeks, 3 months, and 5 months of age (n = 375). Group 1 (n = 250) received 25 mug MeNZB and routine immunizations with a fourth MeNZB dose given at 10 months (n = 51). Group 2 (n = 125) received routine immunizations only. Sero-response was a > or =4-fold rise in vaccine strain serum bactericidal antibody titer compared with baseline or a titer of at least 1:8 for baselines <1:4. Reactogenicity was monitored for 7 days after vaccination.
  
  
  RESULTS
  Sero-response in Group 1 was achieved in 53% (95% Confidence interval [CI]: 46-59, n = 239) and 69% (95% CI: 54-80, n = 45) with geometric mean antibody titers of 9 (95% CI: 7-10) and 22 (95% CI: 12-39) after the third and fourth doses, respectively. No negative interference by MeNZB on routine immunizations was detected. There were no serious adverse events judged to be vaccine related.
  
  
  CONCLUSIONS
  In this group of New Zealand infants, 4 MeNZB doses were required to demonstrate titers comparable with those achieved after 3 doses in older children. MeNZB was safe when used concomitantly with routine New Zealand immunizations to 5 months of age.
authors.affiliation: The University of Auckland, Auckland, New Zealand.
authors.forename: Sharon H
authors.initials: SH
authors.lastname: Wong
authors.forename: Diana R
authors.initials: DR
authors.lastname: Lennon
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Jackson
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Stewart
authors.forename: Stewart
authors.initials: S
authors.lastname: Reid
authors.forename: Ellen
authors.initials: E
authors.lastname: Ypma
authors.forename: Jane M
authors.initials: JM
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 R
authors.initials: DR
authors.lastname: Martin
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D008585:Meningitis, Meningococcal / Q000097:blood / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D009520:New Zealand / Q000453:epidemiology; D016037:Single-Blind Method
chemical_list: D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D022401:Meningococcal Vaccines