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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 varicella attenuated live vaccine (VarV-Fd) in children aged 3 to 10 years from Changchun Qijian Biological Products Co., Ltd. (Changchun Qijian) Sex. Methods A total of 2 476 healthy children aged 3 to 10 years old were enrolled. VarV-Fd was injected subcutaneously into the lateral deltoid muscle of the upper arm at a dose of 0.5 ml / (human). The local and systemic reactions were observed and the antibody titer against varicella zoster virus (VZV) in serum before and after immunization was determined by fluorescent antibody to membrane antigen (FAMA) Titer (GMT). Results No adverse reactions occurred in 2 476 subjects within 30 min after vaccination. No other systemic reactions were observed within 7 days after inoculation except for fever (27). Only 1 patient appeared on day 2 after vaccination Regional swelling (diameter of 1 cm) of the local reaction, no other serious adverse reactions. The serum GMT of susceptible population after immunization was 1:33.73, and the positive rate of antibody positive was 100%. Conclusion VarV-Fd produced by Changchun prayer has good safety and immunogenicity in children aged 3 to 10 years.