流行性出血热双价灭活疫苗的安全性和免疫原性观察

Safety and immunogenicity of inactivated bivalent EHF vaccine in humans

目的 观察流行性出血热 (EHF)沙鼠肾细胞双价灭活疫苗的安全性和免疫原性。方法 以高发疫区现场青壮年为对象 ,基础免疫 3针 ,一年后加强 1针。采用间接免疫荧光试验、微量细胞病变中和试验检测接种后荧光抗体和中和抗体 ,重点观察部分接种者免疫后 72h内的全身体温反应和局部副反应。结果 基础免疫后 2周 ,荧光抗体阳转率及几何平均滴度 (GMT)分别为99 .0 4%、2 4.5 1± 2 .0 6 ;中和抗体阳转率及平均滴度对 76 118(Ⅰ型 )为 91.30 %、18.2 7± 2 .2 1,对UR(Ⅱ型 )为 88.41%、12 .47± 2 .16。基础免疫后 1年 ,荧光抗体阳转率下降为 37.34% ,中和抗体总阳转率近 80 %。加强后 2周 ,荧光抗体和中和抗体阳转率均为 10 0 % ,中和抗体滴度对Ⅰ型为 37.0 9±2 .2 4,对Ⅱ型为 32 .6 1± 2 .0 5。接种后全身体温反应发生率为 0 .46 % ,局部反应发生率为 1.98% ,未见严重副反应发生。结论 流行性出血热双价灭活疫苗近期免疫效果良好 。

Objective Safety and immunogenicity of inactivated bivalent EHF vaccine in humans were evaluated in the epidemic area of Zhejiang province,China. Methods Susceptible persons with negative anti EHF were selected in Jiande county,Zhejiang province to receive 3 doses of inactivated bivalent EHF vaccine at 0,7,28 days. A booster injection was given one year after the primary immunization. Antibody responses were measured in human volunteers by IFA and MCPENT. Local and general reactions were recorded within 72 hours after each vaccination by physicians. Results Two weeks after the primary vaccination,99.04% of the subjects developed significant hantavirus antibody titre measured by IFA which had a 37.34% drop one year after the primary vaccination. Seroconversion rate increased to 100% two weeks after the booster dose. Neutralising antibody titres paralleled this trend with 100% of vaccine recipients producing neutralising antibody two weeks after the primary doses. However, it dropped to 80% one year after the primary vaccination. One hundred percent of the vaccine recipients started to respond two weeks after boosting. The geometric mean titre(GMT) of neutralising antibody against 76 118 and UR were 18.27 ± 2.21 and 12.47 ± 2.16 respectively after the primary injections, but it increased to 37.09 ± 2.24 and 32.61 ± 2.05 respectively after the secondary immunization. General and local reaction rates were 0.46 % and 1.98 %, with no severe side effects observed in the vaccinees. Conclusion The vaccine was well tolerated and could induce good humoral immune response.