我国自行研制的冻干水痘减毒活疫苗的临床效果评价  

Clinical Effect of Freeze-dried Live Attenuated Varicella Vaccine Developed in China

作　　者：周铁群[1] 陈震[1] 王剑锋[1] 英志芳[1] 邱平[1] 范行良[1] 李娟[1] 李长贵[1] 方捍华[1] 陈海平[2] 李秀玲[2] 谢芸[2] 许丽锋[2] 郭绍红[2] 董春明[2] 刘立新[2] 罗耀兴 蔡汉港 张吉凯 徐宁 张铭驱 李建基 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]北京生物制品研究所,北京100025 [3]广东疾病控制中心,广州510300

出　　处：《中国生物制品学杂志》2005年第4期342-345,共4页Chinese Journal of Biologicals

摘　　要：目的考核和评价我国自行分离毒株研制的冻干水痘减毒活疫苗的安全性和免疫原性。方法采用随机、双盲、对照的原则进行设计,在2～6岁健康人群中进行开放式临床观察。结果试验疫苗共接种易感儿童738人,接种后的总体中强发热反应率为5.96%(44738),皮疹水痘样皮疹发生率为0.68%(5738);易感者接种39810PFU、2000PFU以及500PFU病毒量的疫苗后,抗体GMT分别为36.4、34.3和18.6;抗体阳转率分别为100%、98.77%和85.42%。结论我国自行研制的水痘疫苗具有较好的安全性和免疫原性。Objective To evaluate the safety and immunogenicity of freeze-dried live attenuated varicella vaccine prepared with the strain isolated in China.Methods A random,double-blind and control trial in the children aged 2-6 years.Results A total of 738 children was inoculated.The incidence rates of moderate/strong fever and effolrescence/varicella-like efflorescence were 5.96%(44/738) and 0.68%(5/738) respectively.The GMTs of antibody of susceptible children immunized with 39810,2000 and 500 PFU of vaccine were 36.4,34.3 and 18.6,and their antibody positive conversion rates were 100%,98.77% and 85.42% respectively.Conclusion The varicella vaccine was well-tolerated and showed good immunogenicity.

关 键 词：冻干水痘减毒活疫苗 安全性 免疫原性 中国 自主知识产权 

分 类 号：R511.5[医药卫生—内科学] R392.7[医药卫生—临床医学]