两种水痘减毒活疫苗上市后的免疫原性和安全性观察  

Post-Marketing Immunogenicity and Safety of Two Different Live Attemuatal Varicella Vaccine

作　　者：汤妍 杜飞[2] 陈海平 周启富[4] 苏家立 柴文清[5] 夏艳辉 温万敏 陈晓荣 刘志强 黄清霄 刘小琴 黄竹航 梁剑[9] 

机构地区：[1]广东省生物制品与药物研究所,广州510300 [2]四川省疾病预防控制中心,成都610041 [3]中国生物技术股份有限公司,北京100029 [4]雅安市疾病预防控制中心,四川雅安625000 [5]上海生物制品研究所有限责任公司,上海200052 [6]兴宁市疾病预防控制中心,广东兴宁514500 [7]揭东县疾病预防控制中心,广东揭东515500 [8]长春祈健生物制品有限公司,吉林长春130012 [9]广东省疾病预防控制中心,广州511430

出　　处：《中国疫苗和免疫》2014年第3期241-244,共4页Chinese Journal of Vaccines and Immunization

基　　金：广东省疫苗安全重点科学研究基地(编号:2012A061300003)

摘　　要：目的以比利时葛兰素史克（GlaxoSmithKline，GSK）生物制品公司生产的威可檬（Varilrix）冻干水痘减毒活疫苗（Varicella Attenuated Live Vaccine，Freeze—dried；VarV—Fd）作为对照，评价上海（Shanghai，SH）生物制品研究所有限责任公司生产的VarV—Fd的免疫原性和安全性。方法采用随机、双盲、对照方法，对广东省和四川省的467名1—3岁儿童进行了临床观察，比较接种两种VarV—Fd后的抗体（模抗原免疫荧光抗体法，Fluorescent Antibody to Membrane Antigen，FAMA）阳转率和免疫成功率，抗体几何平均滴度（Geometric Mean Titer，GMT）和不良反应发生率。结果接种SHVarV-Fd和GSK VarV—Fd后，抗体阳转率和免疫成功率分别为81．04％和81．59％，GMT分别为1：8．829和1：9．671，不良反应发生率分别为10．17％和7．36％。抗体阳转率和免疫成功率（χ^2=0．020，P=0．886）、GMT（t=0．786，P=0．432）、不良反应发生率（χ^2=1．151，P=0．283）的差异均无统计学意义。结论SH VarV-Fd与GSK VarV-Fd均具有良好的免疫原性和安全性。Objective To evaluate immunogenicity and safety of freeze-dried varicella attenuated live vaccine （VarV-Fd） produced by Shanghai （SH） Institute of Biological Products, using Varilrix, VarV-Fd produced byBelgium GlaxoSmithKline（GSK） Biologicals as a control. Methods A randomized, doubleblind, controlledclinical trial was conducted, with 467 children, aged 1 to 3 years, from Guangdong and Sichuang province. We compared two types of VarV-Fd antibodies after vaccination （Fluorescent Antibody to MembraneAntigen, FAMA）, seroconversion and success rate of immunization, antibody geometric mean titers （ GMT）, and incidence rates of adverse reactions. Results The SH VarV-Fd and GSK VarV-Fd antibody seroconversion and success rates of immunization were 81.04% and 81.59% , respectively. The antibody GMTs were 1：8. 829 andl ：9. 671, and the incidence rates of adverse reactions were 10. 17% and 7.36% ,respectively. The rate of antibody seroconversion and success immunization （χ^2=0. 020,P =0.886 ）,the antibody GMT （t = 0. 786,P = 0432） and the incidence of adverse reactions （χ^2 = 1. 151, P = 0. 283 between the two VarV-Fd groups had no statistically significant difference. Conclusion SH VarV-Fd and GSK VarV-Fd showed good immunogenicity and safety.

关 键 词：冻干水痘减毒活疫苗 免疫原性 安全性 

分 类 号：R512.4[医药卫生—内科学] R186[医药卫生—临床医学]