Immunogenicity of 2 Serogroup B Outer-Membrane Protein Meningococcal Vaccines

作者：Jordan W. Tappero, Rosanna Lagos, A. Maldonado Ballesteros, Brian Plikaytis, D Williams, Janet K. Dykes, L L Gheesling, G M Carlone, E. Arne Høiby, Johan Holst, Hanne Nøkleby, Einar Rosenqvist, Gustavo Sierra, Concepción Campa, Franklin Sotolongo, J Vega, J Garcia, Patricio Herrera, Jan Poolman, Bradley A. Perkins · 发表于：JAMA · 年份：1999 · DOI：10.1001/jama.281.16.1520 · 被引用次数：371 · 研究领域：Bacterial Infections and Vaccines、Pneumonia and Respiratory Infections、vaccines and immunoinformatics approaches

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 SBA 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 3...