Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway.
For more than 15 years, Norway has had the highest incidence of meningococcal disease in northern Europe, with 80% of cases being due to serogroup B meningococci. The case-fatality has remained high, at about 10%. In this study, an outer membrane vaccine, which had previously been shown to induce an increase in bactericidal antibodies to the parent strain, was assessed in a large-scale, randomised, double-blind trial. From October, 1988, 171,800 students in secondary schools volunteered to take part in a double-blind, placebo-controlled, efficacy trial with school as the randomisation unit. Hospitals and clinics that routinely receive patients with infectious disease were asked to report urgently all cases of suspected meningitis and/or septicaemia in 13-21-year-old students in Norway. These cases were registered and further investigated according to a detailed protocol. 89 out of the 221 cases investigated by June 3, 1991, were shown to be severe systemic disease due to group B meningococci. 36 cases in 35 schools took part in the trial (11 schools with vaccinated students and 24 with students given placebo). The calculated rate of protection was thus 57.2% (p = 0.012, one-sided test). The findings suggest that, although the vaccine conferred protection against group B meningococcal disease, the effect was insufficient to justify a public vaccination programme.
National Institute of Public Health, Oslo, Norway.
G
G
Bjune
E A
EA
Høiby
J K
JK
Grønnesby
O
O
Arnesen
J H
JH
Fredriksen
A
A
Halstensen
E
E
Holten
A K
AK
Lindbak
H
H
Nøkleby
E
E
Rosenqvist
D000293:Adolescent; D000328:Adult; D000942:Antigens, Bacterial / Q000008:administration & dosage*; D016667:Bacterial Capsules; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage*; D001428:Bacterial Vaccines / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004196:Disease Outbreaks / Q000517:prevention & control*; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008585:Meningitis, Meningococcal / Q000453:epidemiology / Q000517:prevention & control*; D022401:Meningococcal Vaccines; D009345:Neisseria meningitidis / Q000276:immunology*; D009664:Norway / Q000453:epidemiology; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage*; D014611:Vaccination
D000942:Antigens, Bacterial; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; C039455:capsular polysaccharide, meningococcal group B