国产与进口麻疹-流行性腮腺炎-风疹联合减毒活疫苗的免疫原性和安全性观察  

Safety and Immunogenicity of the Imported and Domestic Measles,Mumps and Rubella Combined Attenuated Live Vaccine

作　　者：符剑[1] 何寒青[1] 陈恩富[1] 严传富[2] 严睿[1] 尹志英[3] 陈波[2] 李倩[1] 潘金仁[1] 王芝芳[1] 

机构地区：[1]浙江省疾病预防控制中心,杭州310051 [2]开化县疾病预防控制中心,浙江开化324300 [3]衢州市疾病预防控制中心,浙江衢州324000

出　　处：《中国疫苗和免疫》2013年第3期222-226,249,共6页Chinese Journal of Vaccines and Immunization

基　　金：浙江省医药卫生平台重点资助计划"新疫苗综合评价技术平台的建立及应用研究"课题(编号:2012ZDA008)

摘　　要：目的观察国产与进口麻疹-流行性腮腺炎(腮腺炎)-风疹联合减毒活疫苗(Measles,Mumpsand Rubella Combined Attenuated Live Vaccine,MMR)在常规免疫接种中的安全性和免疫原性。方法采用随机双盲对照研究设计,对初次免疫(初免)接种上海生物制品研究所(简称"沪")或葛兰素史克生物制品公司(简称"GSK")MMR的免疫原性进行比较;同时通过全省疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测系统,对常规免疫接种MMR进行安全性评价。结果儿童初免接种MMR后,沪MMR组的麻疹、腮腺炎抗体阳转率为99.54%、86.76%,均显著高于GSK组的95.83%(Χ2=6.66,P=0.010)、79.17%(Χ2=4.44,P=0.035);两组风疹抗体阳转率接近(92%～93%;Χ2=0.17,P=0.676)。301384名常规免疫接种MMR的儿童随访6个月后,共报告AEFI个案42例,其中异常反应10例,发生率为3.32/10万,无严重异常反应。结论国产与进口MMR大规模常规免疫接种具有良好的安全性,初免接种后均可获得良好的针对麻疹、腮腺炎、风疹的免疫学效果,其中腮腺炎免疫原性相对较低。Objective To observe the safety and immunogenicity of the imported and domestic measles,mumps and rubella combined attenuated live vaccine （ MMR ） in routine immunization program.Methods A randomized,double-blind,controlled trail design was conducted to compare the immunogenicity of domestic MMR （ Manufactured by Shanghai Institute of Biological Products,＂Hu＂） and imported MMR （＂GSK＂ Manufactured by Glaxosmithkline ） MMR.Adverse events following immunization （ AEFI ） surveillance system in Zhejiang province was used to evaluate the safety of MMR when vaccinated during routine immunization.Results The seroconversion rate rate of measles and mumps after vaccinated with Hu MMR were 99.54 % and 86.76 % respectively,the seroconversion rate produced by GSK were 95.83 %（Χ2=6.66,P=0.010 ）,79.17 %（Χ2=4.44,P=0.035 ） respectively.The seroconversion rate of Hu MMR is much higher than GSK MMR.The sero-conversion rate against rubella was similar between two groups （ 92 %93 % ;Χ2=0.17,P=0.676 ） .42 AEFI cases were reported from 301,384 children vaccinated with MMR in routine immmunzaiton during 6 months follow-up,and there were 10 cases belongs to adverse eventsincidence rate was 3.32 per 100,000 ）,and no serious reaction reported.Conclusion MMR has high safety in routine immunization.Both GSK MMR and Hu MMR showed a good immunogenicity,while the relative lower immunogenicity was founded against mumps.

关 键 词：麻疹-流行性腮腺炎-风疹联合减毒活疫苗 随机双盲对照试验 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]