钩端螺旋体外膜疫苗的反应性和免疫效果研究

对国内首次研制的钩端螺旋体外膜疫苗接种人体的反应性，血清学效果和流行病学效果进行研究。先后对两价（含黄疸出血群赖型，七日热群七日热型），三价（含黄疸出血群赖型，七日热群七日热型，流感伤寒群流感伤寒型，五价（含黄疸出血群赖型，七日热群七日热型，流感伤寒群流感伤寒型，秋季热群秋季热型，犬群犬型）外膜疫苗，菌体疫苗和安慰剂，分组进行全身和局部反应观察；并以显微镜凝集试验测定各型抗体；对两价外膜疫苗进行流行病学保护效果考核。结果两价和多价钩体外膜疫苗反应轻微，安全性良好；血清学效果显示，抗体阳转率和滴度均高于同期相应菌体疫苗诱导的同型抗体水平2倍以上，提示外膜疫苗有较好的免疫原性，流行病学效果在湖北省荆州和石首两市考核，按血清学阳性病例统计，其保护率可达95．57％以上。说明上述疫苗性质稳定，反应轻微，安全性良好，血清学效果理想，两价疫苗有较好的保护效果，可以逐步推广应用。

Study on reactogenicity and immunological efficacy of the leptospiral outer membrane vaccine

To evaluate the reactogenicity and serological and epidemiological effects of the leptospiral outer membrane(OM) vaccine first developed in China.we investigated the local and systemic reactions,antibody responses,and protective efficacy induced by bivalent,trivalent,or pentavalent OM vaccines.The whole cell vaccines and placebo were used as controls.Antibodies to different serovars of leptospira were measured by microscopic agglutination test(MAT).The results showed that the adverse reactions caused by OM vaccines were mild.The seroconversion rates and antibody titers were two times higher than those induced by the corresponding whole cell vaccines,suggesting that the OM vaccines were immunogenic.The protective efficacy of the bivalent OM vaccine was up to 95.5%.It is concluded that OM vaccines are stable,immunogenic,and safe and the bivalent vaccine may provide good protection and is suitable for expanded use.