建德市肾综合征出血热Ⅰ型灭活疫苗随机对照现场试验  

A Randomized Controlled Field Trial of Type Ⅰ Inactivated Vaccine against Hemorrhagic Fever with Renal Syndrome in Jiande County

作　　者：阮玉华[1,2] 徐校平[1,2] 翁寿清 童政 邵守坤[1,2] 周卫群 陈丽华 汪群 方利红 徐哲 严琴 车焱 张军 邓新清[1,2] 柳炜 周联娣[1,2] 赵守军 顾惠心[1,2] 叶克龙 徐志一[1,2] 

机构地区：[1]上海医科大学流行病学教研室 [2]浙江省建德市卫生防疫站

出　　处：《中国公共卫生》1999年第7期574-576,共3页Chinese Journal of Public Health

摘　　要：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。Objective:Evaluation on the antibody reaction and epidemiology effect of type Ⅰ inactivated vaccine against hemorrhagic fever with renal syndrome(HFRS).Materials and Methods:After fellowing up 48 months of a randomized controlled field trial of type Ⅰ inactivated vaccine against HFRS,indirect immunofluorescent method(IFA) and Mcro CEP method (MCPENT) were used in testing the titer of IgG and neutralizing antibody in series sera of IFA negative antibody before vaccine given respectively;Epidemiology effect of type Ⅰ inactivated vaccine against HFRS was studied.Results:The side effects of vaccine was 3 78%.The sera conversion rate of IFA and MCPENT after two weeks of vaccine given before booster、after two weeks、two years and three years of booster were 65 6% and 50 0%,and 3 8%,and 0 0%,and 83 3%,and 75 0%,and 16 7%,and 6 7%,and 12 0% and 4 0% respectively;also,the GMT of that IFA and MCPENT were 13 3 and 3 9,5 1 and 2 5,14 1 and 4 9,1 7 and 1 1,and 1 3 and 1 1 respectively.After fellowing up 48 months,no HFRS case was found among the vaccinees who received the whold schedule vaccinations,while 15 and 20 HFRS case were confirmed in the control group matched to the whole schedule vaccinees and in the other group of vaccinees no given respdectively.The protective efficacy of the tested vaccine was 100%.There were 23 and 10 HFRS cases of type Ⅰ and Ⅱ、2 HFRS cases of on type.Conclusion:The middle term of epidemiology effect of type Ⅰ inactivated vaccine against HFRS was good and antibody level of vaccine induced droped more after four years.The randomized controlled fields of type Ⅰ inactivated vaccine against HFRS should be continued to fellow up so as to received long term epidemiology effect of the vaccine.

关 键 词：肾综合征出血热 灭活疫苗 免疫学效果 

分 类 号：R512.803[医药卫生—内科学]