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Tappero JW, Lagos R, Maldonado Ballesteros A, et al. Immunogenicity of 2 Serogroup B Outer-Membrane Protein Meningococcal Vaccines: A Randomized Controlled Trial in Chile. JAMA. 1999;281(16):1520–1527. doi:10.1001/jama.281.16.1520
Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Ga (Drs Tappero, Carlone, and Perkins, Messrs Plikaytis and Williams, and Mss Dykes and Gheesling); Hospital Roberto del Río (Dr Lagos), Centro para Vacunas en Desarrollo-Chile (Dr Lagos), Instituto de Salud Publica (Ms Ballesteros and Dr Garcia), Pan American Health Organization (Dr Vega), and the Universidad de Chile (Dr Herrera), Santiago, Chile; National Institute of Public Health, Oslo, Norway (Drs Høiby, Nøkleby, and Rosenqvist and Mr Holst); Finlay Institute, Havana, Cuba (Drs Sierra, Campa, and Sotolongo); and the Laboratory for Vaccine Development and Immune Mechanisms, National Institute for Public Health and Environmental Protection, Bilthoven, the Netherlands (Dr Poolman). Dr Poolman is now with SmithKline Beecham Biologicals, Rixensart, Belgium.
Context Meningococcal disease occurs worldwide, and serogroup
B disease accounts for a large proportion of cases. Although persons
younger than 4 years are at greatest risk for serogroup B meningococcal
disease, vaccine efficacy has not been demonstrated in this age group.
Objective To evaluate serum bactericidal activity (SBA) against
homologous vaccine type strains and a heterologous Chilean epidemic
strain of Neisseria meningitidis as a potential correlate for
Design Double-blind, randomized controlled trial conducted between
March 14 and July 20, 1994. All blood samples were taken by December
Setting Santiago, Chile, where a clonal serogroup B meningococcal
disease epidemic began in 1993.
Participants Infants younger than 1 year (n=187),
children aged 2 to 4 years (n=183), and adults aged 17
to 30 years (n=173).
Intervention Participants received 3 doses of outer-membrane
protein (OMP) meningococcal vaccine developed in either Cuba or Norway
or a control vaccine, with each dose given 2 months apart. Blood
samples were obtained at baseline, prior to dose 3, and at 4 to 6 weeks
after dose 3.
Main Outcome Measure Immune response, defined as a 4-fold or
greater rise in SBA titer 4 to 6 weeks after dose 3 compared with
Results Children and adult recipients of either
meningococcal vaccine were more likely than controls to develop an
immune response to the heterologous epidemic strain. After 3 doses of
vaccine, 31% to 35% of children responded to the vaccine vs 5% to
placebo; 37% to 60% of adults responded to vaccine vs 4% to placebo
(P<.05 vs control for all). Infants, however, did not
respond. In contrast, against homologous vaccine type strains, the
response rate was 67% or higher among children and adults and 90% or
higher among infants (P<.001 vs control for all). Subsequent
SBA against 7 isogenic homologous target strains identified class 1 OMP
as the immunodominant antigen.
Conclusions These data suggest that neither serogroup B OMP
meningococcal vaccine would confer protection during a heterologous
epidemic. However, epidemic strain–specific vaccines homologous for
class 1 OMP are promising candidates for the control of epidemic
serogroup B meningococcal disease.
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