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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 10 46 0人 ,全程接种者占 97 30 % ,对照 16 15 9人。全程接种后 2周荧光抗体阳转率为 10 0 0 0 % (6 7/6 7) ,中和抗体阳转率为 44 44 % ,几何平均滴度分别为 72 14和 4 6 3。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 2 4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 10 0 %(95 %可信区间为 96 3%～ 10 0 % )。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。
Objective To observe the safety of type I inactivated vaccine of hemorrhagic fever with renal syndrome after inoculation in a large area of population with high incidence of hemorrhagic fever with renal syndrome in Zhejiang Province, and to evaluate the epidemiological and preventive effects of the vaccine. Methods The specific IgG antibody was detected by IFAT method. The titer of neutralizing antibody was measured by MCPENT method. Results A total of 10 46 0 people were vaccinated, 97 30% of them were vaccinated in the whole process and 16 15 9 were controls. Two weeks after inoculation, the rate of positive immunofluorescence was 100% (67/67). The positive rate of neutralizing antibody was 44.44%. The geometric mean titers were 7214 and 463 respectively. Serum antibodies rose rapidly after immunization and gradually decreased after one year. After vaccination systemic reactions and local reactions slightly. Inoculation group without disease, the control group of 24 cases, 3 cases of death. Epidemiological efficacy of the vaccine was good in the middle of the vaccine (4 years after the basic immunization), with a population protection rate of 10% (95% confidence interval 96 3% -100%). Conclusion The safety of HFRS vaccine is good, and the epidemiology of mid-term epidemic prevention has obvious effect and achieved good economic and social benefits.