甲型肝炎减毒活疫苗免疫原性与保护效果的研究  

Immunogenicity and efficacy of two live attenuated hepatitis A vaccines (H 2 strains and LA 1 strains)

作　　者：徐志一[1] 欧阳佩英[1] 汪萱怡[2] 赵守军[2] 李荣成[3] 龚健[3] 李艳萍[3] 黄全诚[3] 罗东[3] 孟宗达 赵玉良 刘洪斌 张勇[5] 马景臣[5] 夏建玲[5] 刘新立[5] 李燕婷[6] 

机构地区：[1]复旦大学公共卫生学院流行病学教研室 [2]复旦大学医学院分子病毒实验室 [3]广西壮族自治区卫生防疫站 [4]河北省卫生防疫站 [5]河北医科大学 [6]上海市疾病预防控制中心

出　　处：《中华医学杂志》2002年第10期678-681,共4页National Medical Journal of China

基　　金：国家"九五"科技攻关课题资助项目 (9690 60 3 0 1)

摘　　要：目的　观察国产甲型肝炎 (甲肝 )减毒活疫苗 (H2 株与LA 1株 )的免疫原性及预防效果。方法　在广西、河北、上海等地 4 5 72 5 1例观察对象中进行随机对照试验 ,比较接种疫苗组与对照组甲肝发病率 ,观察疫苗保护效果 ;并筛选易感者 ,观察疫苗接种后发生甲肝感染的转归及免疫后甲肝抗体阳性率与持久性。结果　H2 株 (10 7.0 TCID50 )与LA 1株 (10 6.75TCID50 )疫苗保护效果均达 95 % ,抗体阳转率峰值分别出现在疫苗接种后 2个月与 6个月 ,为 94 .9%与 86 .0 % ,3年后抗体阳性率下降至 75 %～ 80 % ,但保护效果不变。结论　国产甲肝减毒活疫苗 (H2 株与LA 1株 )具有很好免疫原性与保护效果 ,可与国外灭活疫苗相媲美。接种者可通过隐性感染获得加强免疫。Objective To assess the efficacy and immunogenicity of two live attenuated hepatitis A vaccines. Methods Randomized and controlled clinical trials were conducted in Guanxi, Hebei and Shanghai, 457 251 children were enrolled. The efficacy for preventing clinical hepatitis A was calculated by the comparison of incidence rate of disease between vaccine group and control group. Susceptible subjects tested anti HAV negative before the study were followed up after vaccination for determination of the immunogenicity and vaccine efficacy to prevent subclinical infection. Results The protective efficacy to prevent clinical infection by both H 2 and LA 1 vaccines were 95%. The peak of seroconversion was observed in 94.9% and 86.0% respectively for the two vaccines. The seroconversion rate decreased to 75%～80% in the third year, but the vaccine protection against clinical hepatitis A has remained unchanged throughout the 3 years. Conclusion Both strains of the live attenuated hepatitis A vaccines have good immunogenicity and high protection against clinical disease, the efficacy to prevent subclinical infection is not significant. The subclinical HAV infection serves as a natural booster for the vaccinees.

关 键 词：甲型肝炎 减毒活疫苗 免疫原性 保护效果 研究 

分 类 号：R392[医药卫生—免疫学]