水痘减毒活疫苗加强免疫与乙脑减毒活疫苗联合接种的免疫原性和安全性观察  

Immunogenicity and safety study for a booster dose of live attenuated varicella vaccine co-administered with Japanese encephalitis vaccine

作　　者：黄竹航 汤妍 苏家立 陈海平 夏艳辉 陈义建 杨波[3] 刘卫民[4] 张吉凯 HUANG Zhu-hang;TANG Yan;SU Jia-li;CHEN Hai-ping;XIA Yan-hui;CHEN Yi-jian;YANG Bo;LIU Wei-ming;ZHANG Ji-kai(Guangdong Provincial Institute of Biological Products and Materia Medical, Guangzhou Guangdong 510440, China)

机构地区：[1]广东省生物制品与药物研究所,广东广州510440 [2]中国生物技术股份有限公司,北京100029 [3]广州市海珠区疾病预防控制中心,广东广州510288 [4]深圳市罗湖区疾病预防控制中心,广东深圳518000

出　　处：《现代预防医学》2018年第10期1796-1799,共4页Modern Preventive Medicine

基　　金：广东省疫苗临床研究技术服务平台(粤发改高技术函[2016]190号;穗发改[2016]779号);广州市疫苗安全性评价重点实验室建设专项资金(2014SY000009);广东省医学科学技术研究基金项目(A2017104)

摘　　要：目的了解水痘减毒活疫苗加强免疫与乙脑减毒活疫苗联合接种的安全性和有效性,为科学制定相关免疫策略提供依据。方法选择425名约24月龄儿童,分为单独接种水痘疫苗组以及联合接种水痘和乙脑疫苗组,分析加强免疫前后水痘抗体水平和疫苗接种安全性。结果加强免疫前,单独接种组以及联合接种组的水痘抗体阳性率分别为93.90%和100.00%,差异有统计学意义(χ~2=12.113,P<0.001)。联合接种组的水痘抗体GMT高于单独接种组(t=-7.133,P<0.001)。加强免疫后,2组的水痘抗体阳性率均为100.00%。单独接种组的水痘抗体阳转率高于联合接种组(χ~2=24.589,P=0.001)。2组的水痘抗体GMT差异无统计学意义(t=1.662,P=0.097)。单独接种组和联合接种组的不良反应发生率分别为9.52%和12.95%,组间差异无统计学意义(χ~2=1.255,P=0.263),未观察到严重不良事件。结论适龄儿童单独接种水痘疫苗或同时接种水痘与乙脑疫苗均具有良好的免疫原性和安全性。Objective The aim of this was to evaluate the immunogenicity and safety for a booster dose of live attenuated varicella vaccine co-administration with Japanese encephalitis vaccine. Methods A total of 425 children aged about 24 months were recruited and allocated into two groups including live attenuated varicella vaccine（LAV） immunization group and live attenuated varicella vaccine co-administered with Japanese encephalitis vaccine（LAV ＋JEV） immunization group. The levels of varicella antibody before and after immunization and the safety of vaccination were analyzed. Results Before a booster dose, there were significant differences in the antibody seropositive rates between LAV group and LAV ＋JEV group（93.90% vs 100.00%, χ^2=12.113, P〈0.001）. The GMTs for LAV＋JEV group were higher than those for LAV group（t=-7.133, P〈0.001）. After immunization, the antibody seropositive rates were both 100% in LAV ＋JEV group and LAV group. The seroconversion rates of LAV group were higher than that of LAV＋JEV group（χ^2=24.589, P〈0.001）. There were no significant differences in the GMTs between them（t=1.662, P=0.097）. The adverse reactions were reported in LAV group and LAV＋JEV group with a rate of 9.52% and 12.95%, respectively, with no significant difference（χ^2=1.255, P=0.263）. No serious adverse events were observed. Conclusion The vaccination schedule of co-immunization with live attenuated varicella vaccine and Japanese encephalitis vaccine could be recommended to eligible children.

关 键 词：水痘减毒活疫苗 乙脑减毒活疫苗 联合接种 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]