冻干无佐剂Vero细胞CTN狂犬病疫苗安全性和免疫原性研究

陈伟; 郑新雄; 张隆明; 郑景山; 张良豪; 廖学舟; 洪孔清; 祝玉桃; 邓化芳; 郑晓丽; 杨晓明; 黄佐林; 李军; 孙文; 徐葛林

Abstract

陈伟,郑新雄,张隆明,郑景山,张良豪,廖学舟,洪孔清,祝玉桃,邓化芳,郑晓丽,杨晓明,黄佐林,李军,孙文,徐葛林.冻干无佐剂Vero细胞CTN狂犬病疫苗安全性和免疫原性研究[J].Chinese journal of Epidemiology,2009,30(12):1261-1264

冻干无佐剂Vero细胞CTN狂犬病疫苗安全性和免疫原性研究

Evaluation on the safety and efficacy of lyophilized purified human rabies vaccine(CTN-Vero-RV)

Received:April 29, 2009

DOI：

KeyWord: 狂犬病疫苗安全性免疫原性抗体持久性

English Key Word: CTN-Vero-rabies vaccine Safety Efficacy Persistent immune response

FundProject:

Author Name	Affiliation
CHEN Wei	武汉生物制品研究所, 430060
ZHENG Xin-xiong	武汉生物制品研究所, 430060
ZHANG Long-ming	湖北省鄂州市疾病预防控制中心
ZHENG Jing-shan	中国疾病预防控制中心
ZHANG Liang-hao	武汉生物制品研究所, 430060
LIAO Xue-zhou	湖北省鄂州市疾病预防控制中心
HONG Kong-qing	湖北省鄂州市疾病预防控制中心
ZHU Yu-tao	武汉生物制品研究所, 430060
DENG Hua-fang	武汉生物制品研究所, 430060
ZHENG Xiao-li	中国疾病预防控制中心
YANG Xiao-ming	武汉生物制品研究所, 430060
HUANG Zuo-lin	武汉生物制品研究所, 430060
LI Jun	武汉生物制品研究所, 430060
SUN Wen	武汉生物制品研究所, 430060
XU Ge-lin	武汉生物制品研究所, 430060

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Abstract:

目的观察人用冻干狂犬病疫苗(Vero细胞/CTN疫苗株)的安全性、免疫原性和抗体持久性.方法对450名健康志愿者随机分为2组,300人(试验组)接种人用冻干狂犬病疫苗(Vero细胞/CTN疫苗株),150人(对照组)接种进口冻干无佐剂狂犬病纯化疫苗;按照0、3、7、14、28 d免疫程序;观察每针次接种后局部和全身反应.采用快速荧光灶抑制试验(RFFIT)检测0(首剂接种前)、3、7、14、28d血清中和抗体水平(GMT).首剂免疫后365 d采集试验组血样本212份,对照组血样本97份;首剂免疫后730 d采集试验组血样本176份,对照组血样本80份,RFFIT检测GMT.结果所有接种对象均未出现严重局部和全身反应.首剂免疫后3、7、14、28、365和730 d试验组抗体阳转率分别为2.35%、80.78%、100.00%、100.00%、98.58%和73.30%;GMT分别为0.12、1.01、9.83、12.61、3.68和2.81 IU/ml.首剂免疫后3、7、14、28、365和730 d对照组抗体阳转率分别为4.00%、87.20%、100.00%、100.00%、97.94%和76.25%;GMT分别为0.13、1.18、10.24、11.61、4.18和1.92 IU/ml.所有结果试验组与对照组相比差异无统计学意义(P＞0.05).结论人用冻干狂犬病疫苗具有良好的安全性、免疫原性和抗体持久性.

English Abstract:

Objective To observe the safety and efficacy of lyophilized purified human rabies vaccine CTN-Vero RV,CTN strain produced in Vero cells.Methods 450 healthy volunteers were divided into two groups,with 300 of them receiving CTN-Vero-RV(rabies vaccine for human use made in Vero cells with CTN strain)while 150 of them receiving PVRV to serve as control group.All the subjects were immunized on days 0,3,7,14 and 28 at deltoid muscle respectively.Local and systemic reactions were observed and sera were collected for neutralizing antibody testing using RFFIT.365 and 730 days after the first dose,sera from the 212 and 176 subjects of the studied group while 97 and 80 subjects from the control group were collected to test for neutralizing antibody.Results No severe local or systemic reactions were observed after immunization was performed in the two groups.On days 3,7,14,28 and 365 after the first dose,the antibody positive rates appeared to be 2.35%,80.78%,100.00%,100.00%,98.58% and 73.30% in the study group and 4.00%,87.20%,100.00%,100.00%,97.94% and 76.25% in the controls respectively.On day 0,3,7,14,28,365 and 730,GMT of the neutralizing antibody level were 0.12,1.01,9.83,12.61,3.68 and 2.81 IU/ml in the study group while 0.13,1.18,10.24,11.61,4.18 and 1.92 IU/ml were seen in the control group respectively.There were no significant differences in both antibody positive rates and GMT between the two groups on days 3,7,14,28,365 or 730(P＞0.05).Conclusion CTN-Vero-RV was safe and effective as well as could generate a persistent immune response.

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