儿童水痘减毒活疫苗和甲肝减毒活疫苗联合接种免疫原性及安全性的研究  

Immunogenicity and safety of co-immunization of children with live attenuated varicella-zoster virus vaccine and live attenuated hepatitis A virus vaccine

作　　者：徐瑾[1] 沈红杰 李军[1] 吕宛玉 马燕丽 赵升[1] 黄清霄 王瑛杰 张岷 叶莹[1] 郭永豪[1] 张延炀[1] 徐斌 陈海平 

机构地区：[1]河南省疾病预防控制中心,郑州450016 [2]长春祈健生物制品有限公司,130012 [3]中国生物技术股份有限公司,北京100029

出　　处：《中华微生物学和免疫学杂志》2016年第3期197-201,共5页Chinese Journal of Microbiology and Immunology

摘　　要：目的 了解水痘减毒活疫苗和甲肝减毒活疫苗联合接种的免疫原性和安全性,为制订水痘疫苗的免疫程序和策略提供科学依据.方法 选择686名18-24月龄儿童分为3组：水痘和甲肝疫苗联合接种组、水痘疫苗接种组和甲肝疫苗接种组,分析免疫前后水痘抗体和（或）甲肝抗体水平和疫苗接种安全性;水痘血清抗体检测采用膜免疫荧光法测定血清中的抗体水平,甲肝血清抗体检测使用酶联免疫竞争法测定.结果 水痘甲肝联合接种组与水痘接种组免疫后水痘抗体阳转率均为100%,抗体几何平均滴度（GMT）分别为33.37和20.00,二者差异有统计学意义（P〈0.001）,水痘甲肝联合接种组与甲肝接种组免疫后甲肝抗体阳转率均为100%,组间免疫前、免疫后甲肝抗体水平差异均无统计学意义（P=0.94,P=0.77）;水痘甲肝联合接种组、水痘接种组、甲肝接种组接种疫苗后不良事件发生率分别为23.63%、19.08%、28.49%,均为发热和红肿,3组之间差异无统计学意义.结论 水痘和甲肝疫苗联合接种的免疫原性和安全性评价不低于两种疫苗单独接种,两者联合接种具有可行性.Objective To investigate the immunogenicity and safety of co-immunization of children with live attenuated varicella-zoster virus （ VZV） vaccine and live attenuated hepatitis A virus （ HAV） vac-cine.Methods A total of 686 children aged 18-24 months were recruited in Henan province of China and divided into three groups.Children in the three groups were respectively immunized with live attenuated VZV vaccine or live attenuated HAV vaccine alone or in combination.Blood samples were collected from all sub-jects before and one month after vaccination for the detection of seroconversion and seropositive rates.Occur-rence of adverse events was monitored for safety evaluation.Antibody membrane immune-fluorescence assay and enzyme immunoassay were performed to detect the antibodies against VZV and HAV, respectively.Re-sults The seroconversion rates of anti-VZV antibody were both 100% in children received co-immunization or VZV vaccine immunization alone.The geometric mean titer （ GMT） of anti-VZV antibody in co-immuniza-tion group was higher than that of VZV vaccine immunization group （P＆lt;0.001）.The GMT and seroconver-sion rate of anti-HAV antibody in children immunized with live attenuated VZV vaccine and live attenuated HAV vaccine were similar to those immunized with live attenuated HAV vaccine alone （ P=0.94, P=0.77）.Adverse reactions were reported in 156 subjects with a rate of 22.74%, mainly manifested as fever and swelling.No other adverse reactions were observed.No significant differences in the adverse events were observed between the three groups.Conclusion Co-immunization children with live attenuated varicella vaccine and live attenuated hepatitis A virus vaccine provided equivalent immunogenicity and safety in com-parison with immunization the two vaccines alone, indicating the feasibility of co-immunization strategy.

关 键 词：水痘减毒活疫苗 甲肝减毒活疫苗 联合接种 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]