地鼠肾细胞狂犬病纯化疫苗临床研究观察  

Observation on clinical trial ofpurified primary hamster kidney cell rabies vaccine(PHKRV)

作　　者：李薇[1] 刘增顺[2] 王玉琳[1] 邹勇[1] 刘景华[2] 曲小素[2] 董关木[2] 魏至栋[1] 安静[1] 马超[1] 郑学刚[1] 

机构地区：[1]兰州生物制品研究所,兰州730046 [2]中国药品生物制品检定所,北京100050

出　　处：《微生物学免疫学进展》2004年第2期17-19,共3页Progress In Microbiology and Immunology

摘　　要：了解地鼠肾细胞狂犬病纯化疫苗接种安全性及有效性。分别以 1.0ml及 0 .5ml的剂量 ,按暴露后及暴露前免疫程序给 313人接种 ,用小鼠中和试验法检测血清中和抗体效价。结果显示 :临床副反应轻微 ,副反应率为0 .89%～ 15 % ;免疫全量疫苗和半量疫苗的人群均获保护力 ,抗体阳转率为 10 0 % ,免后抗体GMT滴度分别为35 .2IU/ml(n =32 )和 31.4IU/ml(n =37) ,经检验两组无显著性差异 (P>0 .0 5 ) ;免疫全量疫苗和半量疫苗两组的免疫前、后相比 ,经检验有显著性差异 (P <0 .0 5 ) 。To observe the safety and neutralizing antibody response of the purified rabies vaccine (primary hamster kidney cell) after immunization . During phase Ⅱ clinical trials 313 volunteers were divided into 3 groups :1.0ml×5injections, 0.5ml×5injections and 1.0ml×3injections.The neutralizing antibody of sera was detected by mouse neutralization test.The results showed that the vaccine did not cause any severe and moderate abnormal reactions,the slight reaction rate is 0.89% to 15%.The positive seroconversion rates of neutralizing antibody following post-exposure schedules were 100% (GMT=35.2IU/ml) with 1.0ml/dose and 100%(GMT=30.4IU/ml) with 0.5ml/dose respectively.There is a significant difference between pre- and post- immunization. Therefore the vaccine is safe and effective for human use.

关 键 词：地鼠肾细胞 狂犬病纯化疫苗 临床试验 中和抗体 

分 类 号：R392[医药卫生—免疫学]