流行性乙型脑炎纯化灭活疫苗(地鼠肾细胞)安全性及血清学效果研究  

Study on Safety and Effect of Purified Inactivited Japanese Encephalitis Vaccine (Primary Hamster Kidney cell,PHK)

作　　者：李薇[1] 贾丽丽[2] 邹勇[1] 孙振鹏[1] 岳广智[2] 王志伟[2] 童亦兵[3] 庄妍[3] 吴昊[3] 王玉琳[1] 

机构地区：[1]兰州生物制品研究所,甘肃兰州730046 [2]中国药品生物制品检定所,北京100050 [3]贵州省疾病预防控制中心,贵阳550004

出　　处：《中国疫苗和免疫》2009年第4期333-336,共4页Chinese Journal of Vaccines and Immunization

基　　金：甘肃省自然科学基金(ZSOZ1-A25-096-Y)

摘　　要：目的评价流行性乙型脑炎(乙脑)纯化灭活疫苗(地鼠肾细胞)[Purified Inactivited Japanese Encephalitis Vaccine(Primary Hamster Kidney Cell),JEV-I(PHK)]接种安全性及血清学效果。方法共选择943名6月龄～10岁儿童进行Ⅰ、Ⅱ、Ⅲ期临床研究,临床研究用疫苗为兰州生物制品研究所研制,批号20010401,剂量为0.5ml/剂,每剂蛋白含量11.5μg。上臂三角肌肌内注射,0、7d各接种1剂。结果接种人体后副反应轻微,无严重全身及局部反应。共接种1848剂次,101剂次出现发热反应,其中98剂次≤37.5℃,24～72h自行恢复。Ⅰ期接种40人,总反应率2.5%;Ⅱ、Ⅲ期接种903人。另设对照疫苗组JEV-I(Vero细胞)接种101人,总反应率分别为6.2%和14.2%。血清学效果测定表明,在试验组与对照组,免疫前抗体阴性组的抗体阳转率分别为96.9%和84.0%,抗体几何平均滴度(Geometric Mean Titer,GMT)分别为1∶32.8和1∶43.9;免疫前抗体阳性组的抗体≥4倍增长率分别为93.1%和100.0%,抗体GMT分别为1∶167.2和1∶181.0。结论JEV-I(PHK)安全性和血清学效果良好。临床试验注册国家食品药品监督管理局《新药临床研究批件》(批件号2003L00429)。Objective In order to observe the safety and neutralizing antibody response to purified inactivated Japanese encephalitis vaccine （primary hamster kidney cell,PHK）. Methods Phase I、II、III field trials were performed and 943 healthy volunteers aged from 6 months to 10 years were administrated the JEV-I （PHK） vaccine at day 0 and day 7 respectively. Results The vaccine did not cause any severe systemic and local adverse reactions. In phaseⅠ40 healthy volunteers were inoculated and the total reaction rate was 2.5%. In phase II and III,903 healthy volunteers were inoculated JEV-I（PHK） and 101 healthy volunteers were inoculated with the Vero cell-derived JEV vaccine,the total adverse reaction rates were 6.2% and 14.2% respectively. The positive sero conversion rates of neutralizing antibody to the test and the control vaccine in antibody negative group were 96.9% （Geometric Mean Titers,GMT1：32.8） and 84.0% （GMT1：43.9） respectively and in antibody positive group were 93.1% （GMT1：167.2） and 1.00% （GMT1：181.0） respectively. Conclusion The JEV-I（PHK） vaccine is safe and effective. Trial Registration National Food drugs surveillance administrative bureau,＂Medicine Clinical Experiment Written Directive from a Superior＂ number：2003L00429.

关 键 词：流行性乙型脑炎纯化灭活疫苗(地鼠肾细胞) 临床研究 中和抗体 安全性 

分 类 号：R512.32[医药卫生—内科学] R186[医药卫生—临床医学]