摘要
目的观察我国研制的规范化甲型病毒性肝炎（以下简称甲型肝炎）减毒活疫苗Ｈ２株与ＬＡ１株的免疫原性并考核其保护效果。方法１３５３４０名受试儿童以系统随机分组方法，另３６００１２名儿童以整群随机分组方法，分为疫苗接种组与对照组。观察并比较两组甲型肝炎发病率。此外，检测甲型肝炎抗体为阴性的部分易感者，在接种Ｈ２株与ＬＡ１株后２～６个月，抽血检测甲型肝炎抗体阳转率与几何平均滴度（ＧＭＴ）。结果对照组发现甲型肝炎３７例，两株疫苗接种组均未发现病例，保护率均为１００％，两组保护率合并后的９５％可信限下限为９２１％。用于现场研究的Ｈ２株（１０７０ＴＣＩＤ５０）抗体阳转率为９４８７％，ＬＡ１株（１０６７５ＴＣＩＤ５０）为８３１６％。抗体阳转率与疫苗滴度有剂量效应关系。活疫苗接种２次，抗体阳转率达１００％。观察期间未发现任何严重副反应。结论Ｈ２株与ＬＡ１株甲型肝炎减毒活疫苗免疫原性良好。
Objective To study two live vaccines, H 2 and LA 1 strains, both attenuated in growth on human diploid cell culture at lower temperature (32℃) Methods Randomized, controlled trials were performed among half million children. 135 340 children were divided into vaccine or control groups by individual and 360 012 by cluster. Those susceptibles with negative anti HAV were bled at 2 6 months after the vaccination and blood test for anti HAV. Results 37 hepatitis A cases were found in the control group. The protective efficacy of the two vaccines was 100%, and the 95% lower confidence limit (one sided )of combined efficacy of the two vaccines was 92.1%,that was comparable with the two inactivated vaccines produced by SmithKline beecham or Merck Sharp Dhome. Conclusion The vaccines are safe, and the seroconversion to H 2 strain (10 7 0 TCID 50 ) and LA 1 strain (10 6 75 TCID 50 ) is 94 87% and 83 16% respectively.
出处
《中华医学杂志》
CAS
CSCD
北大核心
1998年第4期254-256,共3页
National Medical Journal of China
基金
国家"九五"攻关课题
中华医学基金会资助
