肾综合征出血热双价地鼠肾细胞灭活疫苗的安全性及血清学效果评价

Evaluation on the Safety and Serological Effect of Bivalent Inactivated Vaccine Against HFRS Prepared from Tissue Culture of Hamaster Kidney

目的 :评价肾综合征出血热地鼠肾细胞双价灭活疫苗的安全性及血清学免疫效果。方法 :按统一方法观察接种后副反应发生情况 ,以蚀斑减少中和试验方法测定免疫前后血清中和抗体。结果 :对 10 0人进行系统观察 ,局部反应与全身反应发生率均为 2 .0 0 % ,总反应率为 4.0 0 % ,其中强反应发生率为 1.0 0 % ;无头疼、头晕、恶心、皮疹等全身症状及注射处硬结、痒、烧灼感、淋巴结肿痛等局部症状发生。免疫后Ⅰ型病毒中和抗体阳转率为 92 .5 0 % ,Ⅱ型病毒中和抗体阳转率为 95 .0 0 % ,90 .0 0 %受观察者对两型病毒均阳转。结论

Objective:To evaluate the safety and serological effect of bivalent inactivated vaccine against HFRS prepared from Tissue culture of Hamaster Kidney. Methods:The side-effects were observed after inoculation on the same conditions. The neutralization antibodies (plaque reduction neutralization test, PRNT) were detected before and after inoculation. Results: The side-effects were observed in 100 volunteers. The rates of local and systemic side-effect were 2.00 %, the rate of total side-effect was 4.00 , and the rate of moderate and severe side-effects was 1.00% . No abnormal and coincidence responses were found. Two weeks after the third injection, the rate of seroconversion of type Ⅰ (76-118) and type Ⅱ(UR) neutralization antibody was 92.50 % and 95.00 % respectively. The rate of seroconversion of the two types of neutralization antibody was 90.00 %. Conclusion: The vaccine was safe for the crowd, and the serological effect was satisfied.