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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 observe the clinical response and immunogenicity of Varicella Attenuated Live Vaccine (Freeze-dried; VarV-Fd) produced by Changchun Chih-Bio Biological Co., Ltd. Methods Children aged from 3 to 9 years old and schoolchildren were selected as observation objects. According to the principle of randomized double-blind clinical trial, 5192 subjects were divided into experimental group and control group, in which 2593 were in experimental group and were vaccinated with VarV-Fd; 2599 in control group were vaccinated with measles and mumps Live vaccine. Followed up 30min and 6,24,48,72h and 7,14,21,28d after inoculation, and recorded general reaction and abnormal reaction. Membrane antigen immunofluorescence antibody test was used to detect serum chicken pox antibody in 77 children. The antibody positive rate, geometric MeanTiter (GMT) and fold increase were calculated. Results Of the 2593 patients vaccinated with VarV-Fd, 2 of them showed minor flushing at the injection site and no other reactions or discomfort to other recipients; 77 recipients collected venous blood at the time of inoculation and 1 month after inoculation, Chickenpox antibodies were all positive or ≥ 4-fold increase, positive conversion rate of 100%; pre-immune antibody GMT 1: 2.64, GMT after immunization 1: 52.98, the difference was statistically significant. Conclusion VarV-Fd produced by Changchun Qijian Biological Products Co., Ltd. has good safety and immunogenicity.