冻干水痘减毒活疫苗的安全性和免疫原性研究

Study on Safety and Immunogenicity of the Freeze-dried Varicella Attenuated Live Vaccine

目的观察长春祈健生物制品有限公司生产的冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)的临床反应及免疫原性。方法选择年龄在3～9岁的托幼机构儿童和在校小学生作为观察对象。按照随机双盲对照临床试验原则,将入选的5192名观察对象分为试验组和对照组,其中试验组2593人,接种VarV-Fd;对照组2599人,接种麻疹-流行性腮腺炎联合减毒活疫苗。于接种后30min和6、24、48、72h及7、14、21、28d进行随访,并记录一般反应和异常反应。采用膜抗原免疫荧光抗体试验检测77名儿童血清水痘抗体,计算抗体阳性率、抗体几何平均滴度(Geometric MeanTiter,GMT)及增长倍数。结果接种VarV-Fd的2593人中,有2人注射部位局部出现轻微红晕,其他受种者无其他反应或不适;77名受种者在接种时和接种后1个月采集了静脉血,血清水痘抗体全部阳转或≥4倍升高,阳转率100%;免疫前抗体GMT为1:2.64,免疫后GMT为1:52.98,差异有统计学意义。结论长春祈健生物制品有限公司生产的VarV-Fd具有良好的安全性和免疫原性。

Objective To evaluate the safety,serological and epidemiological effect of the freeze-dried varicella attenuated live vaccine（VarV-Fd） produced by Changchun Keygen.bioligical products co.Methods A random,double-blind control clinical trial was adopted.5192 non-infected children who aged from 3～9 years old were divided randomly into experimental group（2593 children）,which were vaccinated VarV-Fd,and control group（2599 children）,which were vaccinated Measles-Mumps vaccine.General adeverse reactions and abnormal reactions were followed-up 30 min,6h,24h,48h,72h,7d,14d,21d and 28d after immunization.Results 2 children had the local reaction.Antibody of varicella of 77 children was tested by FAMA.The antibody positive rate was 100%（≥1：4）.The GMT of antibody after immunization was 52.98,which increased by 34.08 folds compared with that before immunization.Conclusion The VarV-Fd produced by Keygen was safe and effective.