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首页> 美国政府科技报告 >Efficacy, Safety, and Immunogenicity of a Meningococcal Group B (15:p1.3) OuterMembrane Protein Vaccine in Iquique, Chile
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Efficacy, Safety, and Immunogenicity of a Meningococcal Group B (15:p1.3) OuterMembrane Protein Vaccine in Iquique, Chile

机译：智利伊基克的脑膜炎球菌B组（15：p1.3）外膜蛋白疫苗的功效，安全性和免疫原性

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A meningococcal group B (15.'P1.3) outer membrane protein vaccine was tested forefficacy in a randomized, double-blind controlled study in Iquique, Chile. A total of 40811 volunteers, ages 1-21 years, enrolled in the study. Volunteers received two doses of vaccine six weeks apart by jet injector. Both the experimental vaccine and the control vaccine (Menomune, A, C, Y and W135 meningococcal polysaccharide vaccine) were well tolerated with minor side-effects. Active surveillance for suspected cases of meningococcal disease was conducted for 20 months in Iquique. Eighteen cases of group B meningococcal disease were confirmed during the 20 months. Efficacy was estimated to be 51%) (p-0. 11) for all ages combined in children aged 1-4 no protection was evident, but in volunteers aged 5-21 vaccine efficacy was 70%) (p =0.045). The IgG antibody response by ELISA was characterized by a large booster effect after the second dose, followed by a substantial drop in antibody levels by 6 months. The youngest children had the highest responses. The bactericidal antibody response, on the other hand, was characterized by the lack of a significant booster response, higher responses in the older children, and an increase in the geometric mean titer in the later months of the study in the older children.

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