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...

Full description

Saved in:
Bibliographic Details
Published in:The Lancet (British edition) 1991-11, Vol.338 (8775), p.1093-1096
Main Authors: Bjune, G, Høiby, E.A, Grønnesby, J.K, Arnesen, Ø, Fredriksen, J.H, Lindbak, A-K, Nøkleby, H, Rosenqvist, E, Solberg, L.K, Closs, O, Frøholm, L.O, Lystad, A, Bakketeig, L.S, Hareide, B, Halstensen, A, Holten, E, Eng, J
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antibodies
Antigens, Bacterial - administration & dosage
Bacterial Capsules
Bacterial diseases
Bacterial diseases of the nervous system. Bacterial myositis
Bacterial Outer Membrane Proteins - administration & dosage
Bacterial Vaccines - administration & dosage
Biological and medical sciences
Child
Child, Preschool
Disease Outbreaks - prevention & control
Double-Blind Method
Double-blind studies
Evaluation Studies as Topic
Follow-Up Studies
Human bacterial diseases
Humans
Immunization Schedule
Infant
Infectious diseases
Medical research
Medical sciences
Meningitis
Meningitis, Meningococcal - epidemiology
Meningitis, Meningococcal - prevention & control
Meningococcal disease
Meningococcal Vaccines
Neisseria meningitidis - immunology
Neurological disorders
Norway - epidemiology
Polysaccharides, Bacterial - administration & dosage
Public health
Randomization
Schools
Students
Vaccination
Vaccines
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0140-6736
1474-547X
DOI:10.1016/0140-6736(91)91961-S