国产甲型肝炎灭活疫苗低剂量的免疫原性研究

The Study on Immunogenicity of the Low-dose Incativated Domestic HAV Vaccine

为了观察国产甲型肝炎 (甲肝 )灭活疫苗低剂量多针次的免疫效果 ,在平山县 2个农村筛选 4～ 1 0岁甲肝病毒抗体 (抗 HAV)阴性的 65名易感儿童 ,以自然村随机分为 2组 ,分别接种 1 2 5U/剂 (0、1、6个月 )和 2 50U/剂 (0、6个月 )唐山怡安生物工程有限公司研制的甲肝灭活疫苗 ,观察免疫后局部反应和全身反应 ;检测免疫后 1、6、7个月的血清抗 HAV阳转率和滴度。结果显示 :两种剂量疫苗免疫后无严重的局部和全身副反应。 1 2 5U/剂和 2 50U/剂初免后 ,抗 HAV阳转率分别为 62 5 %和 93 9% ,几何平均滴度 (GMT)分别为 342mIU/ml和 382mIU/ml;6个月阳转率均为 1 0 0 0 % ,GMT分别为 531mIU/ml和 391mIU/ml;全程免疫后 1个月GMT分别为 3 1 70mIU/ml和5 963mIU/ml。表明国产甲肝灭活疫苗 1 2 5U适于儿童使用 ,并可作为研究甲、乙肝联合疫苗的参考剂量。

To evaluate the immunogenicity of the low dose inactivated domestic HAV vaccine (Healive),65 HAV susceptible children,aged 4-10 years old,had been enrolld from two adjacent villages in Pingshan county,Hebei Province The volunteers were randomly divided into two groups,32 of them received three doses of 125U/0 5ml vaccine intra muscularly at 0,1,6 month interval and 250U/0 5ml dose of vaccine in other 33 children for two injections of 0,6 month schedule The anti HAV seroconversion rates and their titers were screened by ELISA Kit at 1,6,7 months after primary injection and one month later after boosting. All serum samples collected were kept at -20℃ and tested by one lot ELISA Kit The results showed that in two groups. Healive inactivated HAV vaccine had no marked side effect neither locally nor systemically The anti HAV seroconversion rates and the GMTs were 62 5%,93 9%, 342mIU/ml and 382mIU/ml for 125U/0 5ml and 250U/0 5ml vaccine respectively 6 months after primary injection,the anti HAV seroconversion rates increased to 100%, and the GMTs were 531mIU/ml, 391mIU/ml one month after boosting, the GMTs were 3170mIU/ml and 5*!963mIU/ml for 125U/0.5ml and 250U/0 5ml vaccine respectively So, 125U/0 5ml Healive inactivated HAV vaccine is applicable for children,it also can be considered as a reference dose to prepare HAV,HBV combined vaccine