Song G, Huang Y C, Hang C S, Hao F Y, Li D X, Zheng X L, Liu W M, Li S L, Huo Z W, Huei L J
Institute of Virology, Chinese Academy of Preventive Medicine, Beiming.
Vaccine. 1992;10(4):214-6. doi: 10.1016/0264-410x(92)90154-c.
An inactivated golden hamster kidney cell culture (GHKC) vaccine against haemorrhagic fever with renal syndrome (HFRS) has been developed in recent years. A monovalent GHKC vaccine (lot 88-17) was prepared with L99 strain of the rat-type hantavirus, adapted in suckling mouse brain, cultivated in GHKC, and inactivated with 0.025% formalin, and a preliminary trial of the vaccine was carried out in a small number of human volunteers with the approval of the Ministry of Public Health, PRC, in order to identify safety and antibody response of the vaccine. Three inoculations were made on days 0, 7 and 28 respectively, by the intramuscular route with 1 ml vaccine each time for every volunteer. No obvious side effect was observed in vaccinees within 3 days after each inoculation. All 12 vaccinees (10 received three inoculations, and two received two inoculations of the vaccine) showed positive seroconversion of IgG antibody (by IFAT and ELISA) and neutralizing antibody (by enzyme focus reduction neutralization test, EFRNT), and 10 of them were still seropositive 180 and 360 days after the first inoculation. These results suggest that this vaccine would be safe for human use, and could effectively induce IgG and neutralizing antibody responses.
近年来，已研制出一种针对肾综合征出血热（HFRS）的灭活金黄仓鼠肾细胞培养（GHKC）疫苗。用大鼠型汉坦病毒L99株制备单价GHKC疫苗（批号88 - 17），该毒株在乳鼠脑内适应后，在GHKC中培养，并用0.025%福尔马林灭活。在中国卫生部批准下，对少数人类志愿者进行了该疫苗的初步试验，以确定疫苗的安全性和抗体反应。每位志愿者分别在第0、7和28天进行三次接种，每次通过肌肉注射1 ml疫苗。每次接种后3天内，疫苗接种者未观察到明显副作用。所有12名疫苗接种者（10人接种三次，2人接种两次）的IgG抗体（通过间接免疫荧光试验和酶联免疫吸附测定）和中和抗体（通过酶斑减少中和试验，EFRNT）均呈血清学阳性转化，其中10人在首次接种后180天和360天仍呈血清学阳性。这些结果表明，该疫苗对人类使用是安全的，并且可以有效诱导IgG和中和抗体反应。
