关键词: 肾综合征出血热, 灭活疫苗, 现场试验, 随机对照

Abstract: To evaluate the safety, immunogenicity and protective efficacy of an inactivated vaccine, prepared from a Hantaan virus, cultured in primary gerbil kidney cell, a randommized-controlled field trial based on family randomization was carried out at an area endemic for hemorrhagic fever with renal syndrome(HFRS). 7866 cases received three basic-immunizations bv intramuscular with a vaccination schedule of 0,7, 28 within one month. The reaction of the vaccine was slight. The seroconvertion rate of the neutralizing anti-Hantaan-virus was 48.0%, with 5. 95 geometric mean titres(GMT), and 81. 3 % seroconvertion rate of ELISA anti-Hantaan-virus, two weeks after the last vaccination. Just before the booster, a year after the basic-immunizations, the positive rate of ELISA antibody dropped to 24. 0 % . Two weeks after the booster, the positive rate increased to 87. 0 % . During the one year period, no HFRS case was found among the vaccinees who received the whole-schedule vaccinations, while 9 HFRS cases were confirmed in the control group, which were matched to the whole-schedule vaccinees. The protective efficacy of the tested vaccine was 100 % (60. 5 % - 100 % ). The result suggested that this inactivated vaccine against HFRS be safety and effective, it provide an useful method for the control of HFRS.