国产单价腮腺炎减毒活疫苗加强免疫的免疫原性和安全性观察  

Immunogenicity and safety of a booster dose of domestic monovalent mumps attenuated live vaccine

作　　者：张晓曙[1] 李红[2] 唐宇[1] 崔晓雨[2] 李长贵[2] 李国强 李晓梅 孟蕾[1] Zhang Xiaoshu;Li Hong;Tang Yu;Cui Xiaoyu;Li Changgui;Li Guoqiang;Li Xiaomei;Meng Lei(Gansu Provincial Center for Disease Control and Prevention,Lanzhou 739000,Gansu,China;National Institute for Food and Drug Control,Beijing 100050,China;Wuwei Municipal Center for Disease Control and Prevention,Wuwei 733000,Gansu,China;Longxi County Center for Disease Control and Prevention,Longxi 748100,Gansu,China)

机构地区：[1]甘肃省疾病预防控制中心,甘肃兰州730000 [2]中国食品药品检定研究院,北京100050 [3]武威市疾病预防控制中心,甘肃武威733000 [4]陇西县疾病预防控制中心,甘肃陇西748100

出　　处：《中国疫苗和免疫》2018年第5期535-538,共4页Chinese Journal of Vaccines and Immunization

摘　　要：目的探讨单价腮腺炎减毒活疫苗（MuV）加强免疫的免疫原性和安全性。方法选择甘肃省两个区县3-6岁接种1剂次含腮腺炎成分疫苗1年以上的健康儿童,接种1剂次研究MuV,采集接种前和接种后28d血样进行腮腺炎抗体检测,观察接种后28d内的不良反应。结果受试者免疫前腮腺炎抗体阳性率为23.8%（73/307）,抗体几何平均滴度（GMT）为1∶1.5;免疫后抗体阳性率为88.9%（273/307）,抗体阳转率为82.7%（254/307）,抗体GMT为1∶9.1。各年龄组免疫后抗体阳转率在79.0%-86.8%之间（x^2=0.60,P=0.605）,抗体GMT在1∶7.8-1∶11.1之间（Z=2.81,P=0.422）。免疫后总不良反应发生率为18.5%（62/335）,未观察到3级及以上不良反应。结论采用研究疫苗对目标人群进行加强免疫具有良好的免疫原性和安全性。Objective To evaluate the immunogenicity and safety of a booster dose of domestic monovalent mumps attenuated live vaccine（MuV）. Methods We enrolled 3-6-year-old healthy children from two districts of Gansu province who had received 1 dose of mumps-containing vaccine at least 1 year prior to study enrollment. Subjects were vaccinated with MuV. We obtained blood samples before and 28 days after booster vaccination for determining mumps antibody levels; adverse events within 28 days of vaccination were recorded. Results The positivity rate of mumps antibodies before vaccination was 23.8%（73/307）, and the geometric mean titer（GMT） was 1∶1.5. The positivity rate increased to 88.9%（273/307） after vaccination, for a seroconversion rate of 82.7%（254/307）. The GMT increased to 1∶9.1. Age-specific seroconversion rates ranged from 79.0% to 86.8%（x^2=0.60,P=0.605）, and GMTs ranged from 1∶7.8 to 1∶11.1（Z=2.81,P=0.422）. The overall incidence of adverse reactions after booster vaccination was 18.5%（62/335）; no grade 3 or above adverse reactions were reported. Conclusions A mumps booster dose was safe and immunogenic.

关 键 词：腮腺炎减毒活疫苗 免疫原性 安全性 

分 类 号：R186[医药卫生—流行病学]