精制甲型肝炎灭活疫苗(Vero细胞)维罗信^(TM)的安全性和免疫原性随机对照研究

Safety and immunogenicity of a new inactivated hepatitis A vaccine(Vero cell):A randomized control trial

目的评价精制甲型肝炎灭活疫苗(Vero细胞)的安全性和免疫原性。方法2005年1～8月在广西恭城县选择1507名健康人群,以随机、双盲、平行对照方法,观察该疫苗的不良反应,抗体阳转率和抗体水平(GMT),应用EIA竞争抑制法检测血清抗甲型肝炎抗体(抗-HAVIgG)。结果成人剂量组试验疫苗全身、局部反应发生率分别为8.80%、2.67%,与对照疫苗(分别为12.41%、4.41%)相比,无显著差异;儿童剂量组试验疫苗全身、局部反应发生率分别为10.60%、2.28%,与对照疫苗(10.71%、2.86%)相比,亦无显著性差异。维罗信首针免疫后1个月,儿童剂量组和成人剂量组的阳转率分别为88.2%、93.8%,两针全程免疫1个月后两组抗体阳转率均达到100%,抗体滴度分别为16447、8555mIU/ml,对照疫苗分别为1946、5881mIU/ml,儿童剂量组抗体滴度与对照组相比有显著性差异。结论精制甲型肝炎灭活疫苗(Vero细胞)在儿童和成人中应用具有良好的安全性,采用0,6个月免疫程序免疫后抗体阳转率达100%,并有高的抗体滴度。

Objective To assess the safety and immunogenicity of a new inactivated hepatitis A vaccine （Vero Cell） .Methods 1507 subjects were selected in Gongcheng City of Guangxi Zhuang Autonomous Region, and the clinical trail was carried out according to the random, double-blind and parallel principle from January to August, 2005. After vaccination by 0, 6 schedule, adverse events of the subjects were observed, the seroeonversion rate and geometric mean titer （GMT） were tested by the competitive inhibition ELISA. Results After immunization, the systemic and local reaction rates of adults were 8.80%And 2.67% respectively, which was no significantly statistical difference compared with control group, 12.41% and 4.41% ; while the rates of children were 10.60 and 2.28% respectively, and no significant statistical difference compared with control group, 10.71% and 2.86%. One month after first dose of vaccination, the seroconversion rates of children and adults were 88.2% and 93.8%, and one month after second dose of vaccination, the rates all reached 100%, the GMTs of children and adults were 16447 mIU/ml and 8555 mIU/ml, which was significant statistical difference in children compared with control group, 1946 mIU/ml and 5881 mIU/ml, respectively. Conclusion The new inactivated hepatitis A vaccine（Vero Cell） has the same result in safety compared with the imported vaccine, and the seroconversion rates was 100% by 0, 6 schedule, with highly antibody titer.