Immunogenicity of 2 serogroup B outer-membrane protein meningococcal vaccines - A randomized controlled trial in Chile

被引:301
作者
Tappero, JW
Lagos, R
Ballesteros, AM
Plikaytis, B
Williams, D
Dykes, J
Gheesling, LL
Carlone, GM
Hoiby, EA
Holst, J
Nokleby, H
Rosenqvist, E
Sierra, G
Campa, C
Sotolongo, F
Vega, J
Garcia, J
Herrera, P
Poolman, JT
Perkins, BA
机构
[1] Ctr Dis Control & Prevent, Meningitis & Special Pathogens Branch, Atlanta, GA 30333 USA
[2] Hosp Roberto del Rio, Santiago, Chile
[3] Ctr Vacunas Desarrollo, Santiago, Chile
[4] Inst Salud Publ, Santiago, Chile
[5] Univ Chile, Santiago, Chile
[6] Natl Inst Publ Hlth, Oslo, Norway
[7] Finlay Inst, Havana, Cuba
[8] Natl Inst Publ Hlth & Environm Protect, Lab Vaccine Dev & Immune Mech, NL-3720 BA Bilthoven, Netherlands
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 1999年 / 281卷 / 16期
关键词
D O I
10.1001/jama.281.16.1520
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 vaccine efficacy. Design Double-blind, randomized controlled trial conducted between March 14 and July 20, 1994, All blood samples were taken by December 1994. 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 SEA titer 4 to 6 weeks after dose 3 compared with prevaccination titer. 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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页码:1520 / 1527
页数:8
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