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研究冻干甲型肝炎灭活疫苗免疫原性、安全性及热稳性 .分别将冻干及液体甲型肝炎灭活疫苗注射小白鼠和恒河猴 ,确定小白鼠 7d存活情况及恒河猴的谷丙转胺酶 (ALT)水平、肝脏病理、抗 -HAVIgG水平 .用同等剂量 (12 80EL·UmL-1)的冻干灭活疫苗与液体灭活疫苗初次及加强免疫后 1周 ,2组猴在食欲、活动性、大便频率及持续时间方面均无异常 ;5 2周观察期内未出现肝脏病理改变及ALT水平异常升高 .冻干灭活疫苗与液体灭活疫苗诱发的抗 -HAV水平无显著差异 ,2组IgG水平均在免疫后第 12周达到初次免疫后的最高水平 ,冻干疫苗组为 12 0 47mIUmL-1,液体疫苗组为 11875mIUmL-1.两组无显著差异 (P >0 .0 5 ) .第 2 4周分别加强免疫同等剂量疫苗后 ,第 2 8周抗 -HAVIgG水平显著提高 ,达到最高水平 ,冻干疫苗组为 412 15mIUmL-1,液体疫苗组为 40 874mIUmL-1.冻干剂型的甲型肝炎灭活疫苗具有液体剂型同样良好的安全性和免疫原性 .
To study the immunogenicity, safety and thermostability of the freeze-dried hepatitis A inactivated vaccine, the mice were injected with lyophilized and liquid Hepatitis A inactivated vaccine respectively to determine the survival of the mice for 7 days, (ALT), hepatic pathology and anti-HAVIgG level.With the same dose (1280EL · UmL-1) of lyophilized inactivated vaccine and liquid inactivated vaccine, There were no abnormalities in appetite, activity, stool frequency and duration in the group of monkeys. No liver pathological changes and abnormal increase of ALT levels were observed in the 5-week observation period.The freeze-dried inactivated vaccine and the liquid inactivated vaccine induced anti- HAV levels were not significantly different between the two groups of IgG levels reached the highest level after the first immunization 12 weeks after immunization, freeze-dried vaccine group was 1247mIUmL-1, liquid vaccine group was 11875mIUmL-1 .No significant difference between the two groups ( P> 0.05) .At the 24th week after boosting the same dose of vaccine respectively, the level of anti-HAVIgG increased significantly at the 28th week, reaching the highest level, with 412 15mIUmL-1 in the lyophilized vaccine group and 40 874 mlUmL-1. The lyophilized hepatitis A inactivated vaccine has a liquid The same type of good safety and immunogenicity.