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为研制包含Ⅰ型和Ⅱ型病毒抗原的肾综合征出血热双价灭活疫苗 ,以适合全国各出血热疫区使用。通过空斑克隆和终末稀释传代的方法选育了 2株出血热I型病毒PS 6和JR C 1。用金黄地鼠肾细胞培养的L99株(Ⅱ型 )病毒疫苗 ,PS 6株病毒疫苗和JR C 1株病毒疫苗以 2∶1∶1的配伍方式试制三批双价疫苗。结果试制的三批双价疫苗自检和中国药品生物制品检定所复检 ,各项指标全部合格。疫苗于室温放置 3周 ,3 7℃放置 2周和 4℃放置 1年、1 5年和 2年 ,效力试验均合格。研制的三批出血热双价疫苗 ,符合《肾综合症出血热灭活疫苗 (双价 )试行规程》的要求 ,疫苗稳定性良好
In order to develop a dual-inactivated vaccine for hemorrhagic fever with renal syndrome that contains type I and type II viral antigens, the vaccine is suitable for use in all epidemic areas of hemorrhagic fever in China. Two hemorrhagic fever type I viruses, PS 6 and JR C 1, were selected by plaque cloning and terminal dilution passage. The three batches of bivalent vaccine were tested in a 2: 1: 1 compatibility mode using golden hamster kidney cell line L99 (type II) virus vaccine, PS 6 virus vaccine and JR C 1 virus vaccine. Results trial of three batches of bivalent vaccine self-test and the China Pharmaceutical and Biological Products Test re-examination, all the indicators were qualified. The vaccine was placed at room temperature for 3 weeks, placed at 37 ° C for 2 weeks and at 4 ° C for 1 year, 15 years and 2 years, and the efficacy tests were performed. Developed three batches of haemorrhagic fever vaccine, in line with the “syndrome of hemorrhagic fever with renal syndrome inactivated vaccine (trial price)” requirement, good vaccine stability