Efficacy, safety, and immunogenicity of a meningococcal group B (15:P1.3) outer membrane protein vaccine in Iquique, Chile. Chilean National Committee for Meningococcal Disease

Vaccine. 1995 Jun;13(9):821-9. doi: 10.1016/0264-410x(94)00037-n.


A meningococcal group B (15:P1.3) outer membrane protein vaccine was tested for efficacy in a randomized, double-blind controlled study in Iquique, Chile. A total of 40 811 volunteers, ages 1-21 years, enrolled in the study. Volunteers received two doses of vaccine six weeks apart by jet injector. Both the experimental vaccine and the control vaccine (Menomune, A, C, Y and W135 meningococcal polysaccharide vaccine) were well tolerated with minor side-effects. Active surveillance for suspected cases of meningococcal disease was conducted for 20 months in Iquique. Eighteen cases of group B meningococcal disease were confirmed during the 20 months. Efficacy was estimated to be 51% (p = 0.11) for all ages combined. In children aged 1-4 no protection was evident, but in volunteers aged 5-21 vaccine efficacy was 70% (p = 0.045). The IgG antibody response by ELISA was characterized by a large booster effect after the second dose, followed by a substantial drop in antibody levels by 6 months. The youngest children had the highest responses. The bactericidal antibody response, on the other hand, was characterized by the lack of a significant booster response, higher responses in the older children, and an increase in the geometric mean titer in the later months of the study in the older children.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Bacterial / biosynthesis
  • Bacterial Outer Membrane Proteins / immunology*
  • Bacterial Vaccines / administration & dosage
  • Bacterial Vaccines / adverse effects
  • Bacterial Vaccines / immunology*
  • Blotting, Western
  • Child
  • Child, Preschool
  • Chile
  • Complement System Proteins / metabolism
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Humans
  • Infant
  • Male
  • Meningitis / immunology*
  • Meningitis / metabolism
  • Meningitis / prevention & control
  • Neisseria meningitidis / immunology*
  • Pharynx / microbiology
  • Porins*
  • Prospective Studies


  • Antibodies, Bacterial
  • Bacterial Outer Membrane Proteins
  • Bacterial Vaccines
  • Porins
  • porin protein, Neisseria
  • Complement System Proteins