Preliminary human trial of inactivated golden hamster kidney cell (GHKC) vaccine against haemorrhagic fever with renal syndrome (HFRS).

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.