title: Safety review: two outer membrane vesicle (OMV) vaccines against systemic Neisseria meningitidis serogroup B disease.
abstract: MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac was developed for control of a B:15:P1.7,16 subtype epidemic in Norway and administered to 180,000 subjects in 28 clinical studies. MeNZB, a daughter vaccine of MenBvac, was developed for a clonal B:4:P1.7b,4 epidemic in New Zealand and administered to 1 million people <20 years. The vaccines were similar regarding reactogenicity profile. Serious adverse events (SAEs) in general and particularly neurologic SAEs were very rare. Despite frequently reported local reactions and fever in those under 5 years, these OMV-based vaccines containing 25 microg antigen can be considered safe for use in all age groups.
authors.affiliation: Norwegian Institute of Public Health (NIPH), P.O. Box 4404, Nydalen, N-0403 Oslo, Norway. hanne.nokleby@fhi.no
authors.forename: H
authors.initials: H
authors.lastname: Nøkleby
authors.forename: P
authors.initials: P
authors.lastname: Aavitsland
authors.forename: J
authors.initials: J
authors.lastname: O'Hallahan
authors.forename: B
authors.initials: B
authors.lastname: Feiring
authors.forename: S
authors.initials: S
authors.lastname: Tilman
authors.forename: P
authors.initials: P
authors.lastname: Oster
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000276:immunology*; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D006805:Human Experimentation; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008589:Meningococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D038541:Neisseria meningitidis, Serogroup B / Q000276:immunology*; D012449:Safety
chemical_list: D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D022401:Meningococcal Vaccines