| 柳炜,徐校平,阮玉华,翁寿清,刘文雪,周卫群,董关木,顾惠心,朱智勇,徐志一.流行性出血热双价灭活疫苗的安全性和免疫原性观察[J].Chinese journal of Epidemiology,2000,21(6):445-447 |
| 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 |
| Received:June 06, 2000 |
| DOI： |
| KeyWord: 出血热，流行性 疫苗 中和抗体 免疫原性 |
| English Key Word: Hemorr hagic fever.epidemic Vaccine Neutralising antibody Immunogenicity |
| FundProject: |
| Author Name | Affiliation | | LIU Wei | Department of Epidemiology,Shanghai Medical University, Shanghai 200032, China | | XU Xiaoping | 浙江省建德市卫生防疫站 | | RUAN Yuhua | Department of Epidemiology,Shanghai Medical University, Shanghai 200032, China | | WENG Shouqing | 浙江省建德市卫生防疫站 | | LIU Wenxue | 浙江省卫生防疫站出血热重点实验室 | | ZHOU Weiqun | 浙江省建德市卫生防疫站 | | DONG Guanmu | 浙江省卫生防疫站出血热重点实验室 | | GU Huixin | Department of Epidemiology,Shanghai Medical University, Shanghai 200032, China | | ZHU Zhiyong | 中国药品生物制品检定所 | | XU Zhiyi | Department of Epidemiology,Shanghai Medical University, Shanghai 200032, China |
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| Abstract: |
| 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,接种副反应率低 |
| English Abstract: |
| Objective Safety and immunogenicity of inactiv ated 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 v accine at 0, 7, 28 days.A booster injectio n was given o ne year after the primary immunizatio n. Antibody responses w ere measured in human v olunteers by IFA and MCPENT.Local and general reactions were recorded within 72 hours after each vaccination by physicians.Results Two weeks after the primary vaccina tio n, 99.04 % of the subjects developed sig nificant hantavirus antibody titre measured by IFA which had a 37.34% drop o ne y ear after the primary v accination.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 vaccina tio n.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 %, w ith no severe side effects observed in the vaccinees.Conclusion The vaccine waswell tolerated and could induce good humoral immune response. |
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