水痘减毒活疫苗安全性与免疫原性观察

目的 评价水痘减毒活疫苗的安全性及免疫原性.方法 按随机、双盲的抽样原则,以国产水痘疫苗为对照,对600名1～12岁儿童接种水痘减毒活疫苗,在接种前后分别采集受试者血清,同时观察其临床反应,利用膜免疫荧光法（FAMA法）检测收集到的血清的水痘抗体滴度,并用统计学方法对结果进行分析.结果 试验苗和对照苗不良事件总反应率分别为30.5%和35.0%,二者比较无统计学差异.水痘易感者血清抗体阳转率分别为100.0%和98.73%;抗体GMT分别为1： 48.6和1： 39.0.水痘非易感者血清抗体4倍增长率分别为89.33%和77.42%;抗体GMT分别为1： 139.10和1： 153.07.两组抗体阳转率无显著性差异,但易感者接种试验疫苗组受试者抗体GMT高于接种对照疫苗组.结论 试验疫苗有良好的安全性和免疫原性,可用于预防水痘-带状疱疹病毒感染.

Evaluation on safety and immunogenicity of live attenuated varicella vaccine

Objective To evaluate the safety and immunogenicity of Shangbairongsbeng live attenuated varicella vaccine. Methods A randomized, double - blind study was carried out in 600 children aged 1 - 12 years in Guilin, Guangxi Province to compare the clinical reaction rates, seroconversion rates and geometric mean titer（GMT） increase of the testing vaccine vs domestic vaccine as control. Results The total incidence reaction rates of the testing vaccine and control vaccine were 30.5% and 35.0% ,above moderate reaction rates were 7.50% and 11.50% respectively. There was no significant statistical difference between the two vaccines. The seroconversion rates in varicella susceptible children of the two vaccines were 100.0% and 98.73%, the GMTs of antibody were 1 ： 48.6 and 1 ： 39.0 respectively. Four time increase rates of antibody in non -susceptible children were 89.33% and 77.42% ,the GMTs were 1：139.10 and 1：153.07 respectively. No significant difference was found in seroconversion rates between the two vaccines, but the GMT of the testing vaccine was higher than the GMT of the control vaccine in varicella susceptible children. Conclusion The safety and immunogenicity of the testing vac- cine is as good as the control vaccine. It can be used to procure the varicella - zoster virus and the immunized age is 1 - 12 years.