麻疹风疹联合减毒活疫苗的安全性及免疫原性观察  

Safety and Immunogenicity of Live Attenuated Measles and Rubella Combined Vaccine

作　　者：梁祁[1] 周伟忠[1] 李靖欣[1] 张秋明[2] 刘书强[2] 李薇[3] 李长贵[3] 朱凤才[1] 

机构地区：[1]江苏省疾病预防控制中心,南京210009 [2]淮安市楚州区疾病预防控制中心,江苏淮安223200 [3]中国食品药品检定研究院,北京100050

出　　处：《中国生物制品学杂志》2011年第12期1490-1493,共4页Chinese Journal of Biologicals

摘　　要：目的观察麻疹风疹联合减毒活疫苗的安全性和免疫原性。方法选择江苏省淮安市楚州区8月龄以上常住健康儿童作为观察对象,分两个阶段观察试验组和对照组麻疹风疹联合减毒活疫苗的安全性及免疫原性,第一阶段入选28名志愿者,主要观察疫苗的安全性,第二阶段入选1 400人,采用单中心、随机、双盲、平行对照的原则,观察两组疫苗接种后不良反应发生率、抗体阳转率、GMT水平及GMT增长倍数。结果第一阶段28名志愿者接种试验疫苗后不良反应总体发生率为14.29%,无3级及3级以上不良反应发生。第二阶段接种后第0～14天内,试验组和对照组预期不良反应总体发生率(分别为28.43%和27.86%)和非预期不良反应/事件总体发生率(分别为3.71%和3.29%)差异均无统计学意义(P>0.05)。第15～28天内,试验组和对照组非预期不良反应/事件发生率(分别为3.43%和3.29%)差异无统计学意义(P>0.05);试验组和对照组血清麻疹抗体阳转率(分别为96.97%和98.44%)及风疹抗体阳转率(分别为96.97%和96.73%)差异均无统计学意义(P>0.05);血清麻疹抗体GMT水平(分别为1∶75.63和1∶64.97)差异有统计学意义(P<0.05),血清风疹抗体GMT水平(分别为1∶276.95和1∶273.13)差异无统计学意义(P>0.05);血清麻疹抗体GMT增长倍数(分别为70.93和60.25倍)差异有统计学意义(P<0.01),血清风疹抗体GMT增长倍数(分别为53.22和52.70倍)差异无统计学意义(P>0.05)。结论试验组麻疹风疹联合减毒活疫苗对8月龄以上健康儿童具有较好的安全性和免疫原性。Objective To observe the safety and immunogenicity of live attenuated measles and rubella combined vaccine.Methods Healthy children aged more than 8 months were selected from resident population in Chuzhou City,Huai＇an City,Jiangsu Province,divided into trial and control groups,and inoculated with live attenuated measles and rubella combined vaccines manufactured by two manufacturers respectively.A total of 28 children were observed for safety of vaccine at the first stage.However,1 400 children were observed for adverse reaction rate,antibody positive conversion rate,GMT as well as its increasing fold at the second stage by a single-center,random,double-blind,parallel controlled trial.Results The total adverse reaction rate of 28 children at the first stage of trial was 14.29%,while no adverse reaction of grade 3 or above was observed.However,at the second stage of trial,the total incidence rates of expected adverse reactions within 0 ～ 14 d after inoculation were 28.43% and 27.86%,while those of unexpected adverse reactions / events were 3.71% and 3.29% in trial and control groups respectively,which showed no significant difference（P 0.05）.Within 15 ～ 28 d after inoculation,and total incidences rates of unexpected adverse reactions / events were 3.43% and 3.29% in trial and control groups respectively,which showed no significant difference（P 0.05）.The positive conversion rates of measles antibody in sera of children were 96.97% and 98.44%,while those of rubella antibody were 96.97% and 96.73% in trial and control groups respectively,which showed no significant difference（P 0.05）.The GMTs of measles antibody in sera of children in trial and control groups（1 ∶ 75.63 and 1 ∶ 64.97 respectively） showed significant difference（P 0.05）,while those of rubella antibody（1 ∶ 276.95 and 1 ∶ 273.13 respectively） showed no significant difference（P 0.05）.The increasing folds of GMTs of measles antibody in trial and control groups（70.93 and 60.25 respectively） showed significant di

关 键 词：麻疹 风疹 联合疫苗 疫苗 减毒 安全性 免疫原性 

分 类 号：R373.11[医药卫生—病原生物学] R392.33[医药卫生—基础医学]