刘晓强;杨海涛;李海燕;双慧;张丽芬;杨双敏;沈红杰;栾鸣;苏畅;汝东宇;

• 1:云南省疾病预防控制中心
• 2:长春祈健生物制品有限公司
• 3:大理大学

摘要(Abstract)：

目的通过与已上市同类疫苗比较,评价在≥13岁健康人群中接种2剂次国产水痘减毒活疫苗(VarV)的免疫原性和安全性。方法采用单中心、随机、双盲、同类疫苗对照的非劣效性试验设计,在云南省某县选择1 200名≥13岁健康人群,随机分为试验组和对照组,按0、42d免疫程序分别接种2剂次试验疫苗和对照疫苗(对照疫苗为另一种已上市的国产VarV),检测受试者免疫前和免疫后30d血清水痘中和抗体,观察免疫后1年内的不良事件,比较两组水痘抗体水平和不良事件发生率。结果试验组、对照组接种2剂次VarV后水痘抗体阳转/≥4倍增长率分别为72.41%(433/598)、71.79%(430/599)(Fisher确切概率法,P=0.811),率差为0.62%(95%CI:-4.46%-5.70%)。两组总不良事件发生率分别为28.93%(173/598)、30.22%(181/599)(Fisher确切概率法,P=0.658)。结论本研究≥13岁健康人群国产VarV中2剂次免疫程序具有良好的免疫原性和安全性,非劣于对照疫苗。

关键词(KeyWords)： 水痘减毒活疫苗;免疫原性;安全性

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 刘晓强;杨海涛;李海燕;双慧;张丽芬;杨双敏;沈红杰;栾鸣;苏畅;汝东宇;

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