人用Vero细胞狂犬病纯化疫苗安全性观察及免疫效果分析  

Safety and Immune Effects of the Purified Vero Cell Rabies Vaccine (PVRV) for Human Use

作　　者：许二萍[1] 朱冰[1] 杨洛贤[1] 黄利明[1] 陈月光[1] 杨森英[1] 李青卿[1] 赵晓鸣[1] 

机构地区：[1]浙江省杭州市疾病预防控制中心,浙江杭州310006

出　　处：《疾病监测》2005年第3期140-142,共3页Disease Surveillance

摘　　要：目的　观察杭州市新引进的常州延申生物技术有限公司生产的人用纯化Vero细胞狂犬病疫苗与法国安万特巴斯德公司生产的狂犬病纯化疫苗(维尔博)的接种安全性和血清学免疫效果。方法　在杭州市疾病预防控制中心犬伤门诊选择于2 0 0 3年7月7～19日间接受狂犬病暴露后免疫者共176人作为观察对象,按接种疫苗类别分为常州狂苗组与维尔博组。按照《预防接种手册》判定标准,国家药品临床管理规定和中国生物制品规程(2 0 0 0年版)狂犬病疫苗免疫检测标准观察免疫接种后全身、局部反应和抗体水平。结果　两组疫苗接种后均无异常反应,常州狂苗组与维尔博组轻度全身反应分别为3 4 1%和3 5 7% ,IgG抗体阳转率均为10 0 % ,GMT分别为4 8 0 9IU/ml和5 2 2 2IU/ml。两组间安全性及免疫学效果差异无显著性。结论　两类人用Vero细胞狂犬疫苗使用安全、无异常反应,副反应率低。Objective The present study was designed to observe the purified vero cell rabies vaccine (PVRV) for human use manufactured by Changzhou Yansheng Biotechnology Co.,Ltd and Weierbo, a purified rabies vaccine produced by Aventis Pasteur Company, both of which were newly introduced into Hangzhou city, for their safety and serological immune effects. Methods 176 rabies sufferers vaccinated after exposure from July,7,2003 to July, 19 at the Animal Bite Clinic of Hangzhou Municipal Center for Disease control and Prevention were chosen as subjects, who were divided into 2 groups, Changzhou rabies vaccine group and Velbo Group, based on the vaccine used. Evaluation criterion described in 'vaccination manual' , National Regulations for Clinical Drug Administration and criterion for rabies vaccine immunodetection defined in the China Biological Products Regulations(2000 edition) were used for assessment of general and local reactions and antibody level.Results No abnormal reactions were seen in both groups. Mild general reactions were seen in Changzhou rabies vaccine group(3.41%) and Velbo group(3.57%), and GMT was 48.09 IU/ml and 52.22 IU/ml respectively. Both groups had a IgG positive seroconversion rate of 100%. There was no significant difference between the two groups as far as safety and immune effects were concerned. Conclusion The two kinds of purified vero cell rabies vaccine (PVRV) for human use prove safe and effective in inducing specific immune protection without abnormal reactions and with a low rate of side effects.

关 键 词：Veto细胞狂犬疫苗 副反应 血清学免疫效果 免疫接种 

分 类 号：R392[医药卫生—免疫学]