冻干水痘减毒活疫苗的接种反应及免疫原性观察

Adverse Reaction and Immunogenicity Induced by Freeze-dried Live Attenu-ated Varicella Vaccine

目的观察国产冻干水痘减毒活疫苗的接种反应及免疫原性。方法选择460名观察对象,于接种后30min、6h、24 h、48 h、72 h、4～10 d进行随访,观察一般反应和异常反应,通过电话和自动报告收集30 d内的异常反应。采用膜免疫荧光抗体法(FAMA)检测观察对象免疫前后的抗水痘-带状疱疹病毒(VZV)抗体水平,并计算抗体阳性率、抗体几何平均滴度(GMT)及增长倍数。结果460名观察对象接种疫苗后,在观察期未观察到严重的局部反应和全身反应,也未观察到异常反应,抗体总阳性率为98.31%,免疫后抗体GMT水平平均为147.38,比免疫前提高38.18倍。6～12岁组免疫后抗体GMT水平高于1～5岁组,且差异有统计学意义。结论国产冻干水痘减毒活疫苗具有良好的安全性和免疫原性。

Objective To observe the adverse reaction and immunogenicity induced by freeze-dried live attenuated varicella vaccine. Methods A total of 460 subjects were immunized with domestic freeze-dried live attenuated varicella vaccine, and general adverse reactions and abnorulal reactions were followed-up 30 rain, 6 h, 24 h, 48 h, 72 h and 4 - 10 d after immunization. The abnormal reactions within 30 d were collected through telephone and the report by subjects themselves. The antibody titers against varicell-zoster virus（VZV） of the subjects before and after immunization were determined by FAMA, and the antibody positive rate as well as antibody GMT and its increasing fold were calculated. Results No severe local or systemic adverse reactions or abnormal reactions were observed in 460 subjects during the whole clinical trial. The total positive of antibody was 98. 31%. The GMT of antibody after immunization was 147. 38, which increased by 38. 18 folds compared with that before immunization. The GMT of antibody in subjects aged 6 - 12 years were significantly higher than those aged 1 - 5 years. Conclusion Domestic freeze-dried live attenuated varicella vaccine showed good safety and immunogenicity.