title: Immunogenicity and safety of monovalent p1.7(h),4 meningococcal outer membrane vesicle vaccine in toddlers: comparison of two vaccination schedules and two vaccine formulations.
abstract: The safety and immunogenicity of two PorA-based meningococcal outer membrane vesicle (OMV) vaccines against the P1.4 serosubtype adsorbed with AlPO(4) or Al(OH)(3) were studied in 134 toddlers. Vaccinations were given three times with an interval of 3-6 weeks or twice with an interval of 6-10 weeks. A vaccination was repeated after 20-40 weeks. Pre- and post-immunization sera were tested for bactericidal activity against an isogenic strain expressing P1.7(h), 4 PorA. Both meningococcal OMV vaccines were well tolerated. The percentage of children with a fourfold increase in bactericidal activity was 96% (AlPO(4)-adjuvated vaccine/2+1 schedule), 100% (AlPO(4)-adjuvated vaccine/3+1 schedule), 93% (Al(OH)(3)-adjuvated vaccine/2+1 schedule) and 97% (Al(OH)(3)-adjuvated vaccine/3+1 schedule). Adsorption with AlPO(4) makes the OMV vaccine more immunogenic than adsorption with Al(OH)(3). Bactericidal activity was highest after the 3+1 schedule, although the response shortly after the primary series was higher in the two-dose priming group.
authors.affiliation: Department of Pediatrics, University Hospital Rotterdam/Sophia Children's Hospital, Dr Molewaterplein 60, 3015 GJ, Rotterdam, The Netherlands.
authors.forename: E D
authors.initials: ED
authors.lastname: de Kleijn
authors.forename: R
authors.initials: R
authors.lastname: de Groot
authors.forename: A B
authors.initials: AB
authors.lastname: Lafeber
authors.forename: J
authors.initials: J
authors.lastname: Labadie
authors.forename: K C
authors.initials: KC
authors.lastname: van Limpt
authors.forename: J
authors.initials: J
authors.lastname: Visser
authors.forename: G A
authors.initials: GA
authors.lastname: Berbers
authors.forename: L
authors.initials: L
authors.lastname: van Alphen
authors.forename: H C
authors.initials: HC
authors.lastname: Rümke
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D001770:Blood Bactericidal Activity; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007114:Immunization; D007115:Immunization Schedule; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000276:Adjuvants, Immunologic; D022401:Meningococcal Vaccines