流行性出血热双价灭活疫苗的安全性和免疫原性观察

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

Abstract

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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