冻干水痘减毒活疫苗安全性及免疫原性观察

Safety and immunogenicity of freeze-dried live attenuated varicella vaccine

目的评价长春祈健生物制品有限公司（简称长春祈健）生产的冻干水痘减毒活疫苗（freeze-dried varicella attenuated live vaccine,VarV-Fd）在3-10岁儿童中的安全性及免疫原性。方法选择2 476名3-10岁的健康儿童,于上臂外侧三角肌附着处经皮下注射VarV-Fd,0.5 ml/（剂·人）。观察局部及全身反应,并采用膜抗原免疫荧光抗体试验（fluorescent antibody to membrane antigen,FAMA）测定免疫前后血清中抗水痘-带状疱疹病毒（varicella zoster virus,VZV）抗体滴度,计算抗体几何平均滴度（GMT）。结果 2 476名观察对象接种疫苗后30 min内均未出现不良反应;接种后7 d内除发热反应（27人）外,未见其他全身反应;仅1人在接种疫苗后第2天出现注射部位红肿（直径为1 cm）的局部反应,未见其他严重不良反应。易感人群免疫后血清的GMT为1∶33.73,抗体阳转率为100%。结论长春祈健生产的VarV-Fd在3-10岁儿童中具有良好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of freeze-dried live attenuated varicella vaccine manufactured by Changchun Keygen Biological Products Co., Ltd., Var V-Fd, in children at ages of 3 - 10 years. Methods A total of 2 476 healthy children at ages of 3 - 10 years were injected s. c. with Varv-Fd at a dosage of 0. 5 ml, and observed for local and systemic reactions. The antibody titers against varicella-zoster virus（VZV） in sera of children before and after immunization were determined by fluorescent antibody to membrane antigen（FAMA） test, based on which the GMTs of antibody were calculated. Results No adverse reactions were observed in the 2 476 children within 30 min after vaccination. Except the fever in 27 children within 7 d after vaccination, no other systemic adverse reactions were ob-served. However, except one case of local redness and swelling in injection site on day 2 after vaccination, no other severe local adverse reactions were observed. The GMT of antibody in sera of chilaredn after vaccination was 1 ∶ 33. 19, while the antibody positive rate was 100%. Conclusion Var V-Fd showed high safety and immunogenicity in children at ages of3 - 10 years.