在建德市肾综合征出血热Ⅰ型灭活疫苗随机对照现场，采集免前ＨＦＲＳ抗体阳性者系列血清，检测血清中间接免疫荧光抗体（ＩＦＡ）和中和抗体（ＭＣＰＥＮＴ）；观察疫苗保护发病的效果。结果疫苗副反应率为３７８％。免后二周、加强前、加强后二周、加强后二年和三年血清抗体ＩＦＡ和ＭＣＰＥＮＴ阳性率分别为６５６％、５００％、３８％、００％、８３３％、７５０％，１６７％、６７％、１２０％、４０％；其血清抗体ＩＦＡ和ＭＣＰＥＮＴ滴度分别是１３３、３９、５１、２５，１４１、４９、１７、１１、１３、１１。经过４８个月（４年）的随访期，全程接组种无一病例发生，全程对照组发病１５人，其余未种组发病２０人，疫苗保护率１００％。在３５例ＨＦＲＳ病例中，Ⅰ型病例２３人，Ⅱ型病例１０人，２例未分型。表明疫苗的中期防病效果较好，免后四年抗体水平下降很快；该现场还需继续随访以获得更长时间疫苗保护发病的情况。 In the randomized controlled trial of type I inactivated vaccine against renal syndrome hemorrhagic fever with renal syndrome in Jiande City, serum from pre-HFRS positive individuals was collected to detect serum IFA and MCPENT. Effect. Results Vaccine side reaction rate was 378%. The positive rates of IFA and MCPENT in serum antibody were 656%, 500%, 38%, 00%, 83  3%, 750%, 167%, 67%, 120%, 4  0%. The titers of serum antibody IFA and MCPENT were 133,39,51 , 25,141,49,17,11,13,11. After 48 months (4 years) follow-up period, there was no case occurred in the whole course of the disease. There were 15 cases in the control group and 20 cases in the other groups. The vaccine protection rate was 100%. Among the 35 HFRS cases, 23 were type I, 10 were type II and 2 were non-typed. The results showed that the vaccine had better anti-disease effect in the medium term, and the level of antibody in the first four years after the exemption dropped rapidly. The site also needed to be followed up for longer time to protect the vaccine.