儿童和成人接种麻疹风疹联合减毒活疫苗的安全性及免疫原性评价  

Safety and immunogenicity of live attenuated measles and rubella combined vaccine in children and adults

作　　者：刘雅菲 徐碧丹 王燕亭 张浩 常先芸 张磊 刘建凯[1] 李贵凡[1] LIU Ya-fei;XU Bi-dan;WANG Yan-ting;ZHANG Hao;CHANG Xian-yun;ZHANG Lei;LIU Jian-kai;LI Gui-fan(Beijing Minhui Biotechnology CO,.LTD.,Beijing 102600,China)

机构地区：[1]北京民海生物科技有限公司,北京102600

出　　处：《中国生物制品学杂志》2021年第1期64-68,共5页Chinese Journal of Biologicals

摘　　要：目的评价我国儿童和成人接种麻疹风疹联合减毒活疫苗的安全性及免疫原性,为科学适当调整免疫策略提供依据。方法选择1 500名8月龄以上儿童作为儿童组,2 000名18~50岁成人为成人组,分别接种麻疹风疹联合减毒活疫苗,分析疫苗接种安全性及免疫前后麻疹及风疹抗体水平。结果儿童组和成人组的局部不良反应发生率分别为0.07%和0.95%,全身不良反应发生率分别为0.73%和0.05%。免疫后两组的麻疹抗体阳性率均为100%;阳转率儿童组(98.5%)显著高于成人组(16.2%),且差异有统计学意义(P <0.001);两组间的麻疹抗体GMT差异无统计学意义(P=0.063)。免疫后儿童组和成人组的风疹抗体阳性率分别为96.4%和100%;阳转率儿童组(94.8%)显著高于成人组(20.4%),且差异有统计学意义(P <0.001);儿童组的风疹抗体GMT显著低于成人组(P <0.001)。结论儿童和成人接种麻疹风疹联合减毒活疫苗均具有良好的安全性及免疫原性。Objective To evaluate the safety and efficacy of live attenuated measles and rubella combined vaccine in children and adults in China and provide a basis for scientific and proper modification of immune strategy.Methods A total of 1 500 children at ages of more than 8 months and 2 000 adults at ages of 18 to 50 years were recruited as two groups and inoculated with live attenuated measles and rubella combined vaccine(MR)separately to analyze the safety of vaccine as well as measles and rubella antibody levels before and after vaccination.Results The local adverse reaction rates in children and adults were 0.07% and 0.95%,while the systemic adverse reaction rates were 0.73% and 0.05%,respectively.Both the positive rates of measles antibody in two groups were 100% after vaccination,while the seroconversion rate in children(98.5%) was significantly higher than that in adults(16.2%)(P < 0.001).However,there was no significant difference between the GMTs of measles antibody in two groups(P = 0.063).The positive rates of rubella antibody in children and adults after vaccination were 96.4% and 100% respectively,while the seroconversion rate in children(94.8%) was significantly higher than that in adults(20.4%)(P < 0.001).However,the GMTs of rubella antibody in children was significantly lower than that in adults(P < 0.001).Conclusion Live attenuated measles and rubella combined vaccine showed good safety and immunogenicity in both children and adults.

关 键 词：麻疹 风疹 联合减毒活疫苗 安全性 免疫原性 

分 类 号：R186[医药卫生—流行病学] R373.11[医药卫生—公共卫生与预防医学]