肾综合征出血热I型疫苗中期流行病学效果研究

摘要

目的 观察肾综合征出血热I型灭活疫苗在浙江省肾综合征出血热高发疫区大面积人群接种后的安全性,考核流行病学防病效果。方法 采用IFAT法测特异性IgG抗体,用MCPENT法测中和抗体滴度。结果 共接种10460人,全程接种者占97.30%,对照16159人。全程接种后2周荧光抗体阳转率为100.00%(67/67),中和抗体阳转率为44.44%,几何平均滴度分别为72.14和4.63。加强免疫后血清抗体迅速回升,1年后又逐渐下降。预防接种后全身反应和局部反应轻微。接种组无发病,对照组发病24例,死亡3例。疫苗中期(基础免疫后4年)流行病学防病效果良好,人群保护率达100%(95%可信区间为96.3%～100%)。结论 HFRS疫苗安全性良好，中期流行病学防病效果明显,取得了良好的经济和社会效益。%Aim Observe the safety and epidemiological efficacy character ofHFRS vaccine in the focus population with high incidence of HFRS in Zhejiang province.Methods Immunofluorecent antibody assay was used in testing specific IgG antibody and Mcro-CPE Method was used in testing the titer of neutralizing antibody.Result 10460 people were vaccinated ,97.30% of them completed their vaccination with full doses.16 159 non -vaccinated people living in the same areas as the control group. Two weeks after the injection , the seroconversion rate by Immunofluorecent antibody test(IgG) and neutralization test were 100.00%(67/67) and 44.44%, the GMTs of them were 72. 14 and 4.63 respectively.Before reinforce,the rate of seroconversion of immunofluorescent antibody by IFA method and the rate of seroconversion of neutralizing antibody by the Mcro-CPE method were all low.After reinforce,the rates of seroconversion of immunofluorescent antibody and neutralizing antibody were all going up.But they all droped again after one year,the reaction of vaccine was little.The vaccinated group had no patient and the control group had 24 patients and 3 died. According to the middle-term(4 years after primary immunization) observation, the vaccine was effective,and its protection rate in population was 100.00%(95% CI is 96.3%～100%).We have found some antibodies dependent on immunization enhancement phenomenon among the inoculated population,but still need to observe.Conclusion HFRS vaccine has a well effect in epidemiology in the middle-term.