肠道病毒71疫苗临床前过敏性评价  

Preclinical evaluation on hypersusceptibility of enterovirus 71 vaccine

作　　者：周晓冰[1] 孙立[1] 姜云水 霍艳[1] 汪巨峰[1] 周康凤 李波[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心药物非临床安全评价研究北京市重点实验室,北京100176 [2]浙江普康生物技术股份有限公司,浙江杭州310013

出　　处：《中国生物制品学杂志》2015年第8期777-779,共3页Chinese Journal of Biologicals

基　　金：十二五"重大新药创制"科技重大专项(2012ZX09302001)

摘　　要：目的评价肠道病毒71(enterovirus 71,EV71)疫苗的临床前过敏性反应。方法将Hartley豚鼠随机分为EV71疫苗低剂量(320 EU/只)组、高剂量(640 EU/只)组、阴性对照组(生理盐水)和阳性对照组[牛血清白蛋白(bovine serum albumin,BSA)]。各组豚鼠均经头背部皮下注射相应药物进行致敏,隔天致敏1次,共3次,并于末次致敏后第10天,经耳缘静脉注射相应药品进行激发,测定不同给药时期各组豚鼠的体重变化,观察记录临床反应及相关症状出现和消失的时间。结果在实验期间,各组动物体重均呈增长趋势;致敏给药期间至激发给药前,各组豚鼠均未发现异常临床症状;激发后,阳性对照组豚鼠过敏症状的阳性率达100%,其中5只为极强阳性,1只为强阳性,而阴性对照组、EV71疫苗低、高剂量组均未见过敏症状。结论在拟定的临床给药剂量下,豚鼠对EV71疫苗全身过敏反应为阴性,本实验为该疫苗进行Ⅰ期临床试验提供了实验依据。Objective To evaluate the preclinical hypersusceptibility of enterovirus 71（EV71） vaccine. Methods Hartley guinea pigs were randomly divided into four groups, and injected s.c. with EV71 vaccines at low（320 EU） and high（640 EU）dosages, physiological saline（negative control）and bovine serum albumin（positive control）respectively,every other day for 3 times for sensitization. The guinea pigs were injected i.v. with the corresponding drugs 10 d after the last sensitization for excitation. The bodyweights of animals at various phases as well as the times when clinical reactions and the relevant symptoms appeared and disappeared were recorded. Results During the observation, the body weights of animals in various groups showed increasing trends. No abnormal symptoms appeared between sensitization and excitation.After excitation, allergic symptoms appeared in 100% of animals in positive control group, of which extremely strong positive in five and strong positive in one animal. However, no allergic symptoms were observed in negative control as well as low and high dose EV71 vaccine groups. Conclusion No systemic allergic reactions were observed in guinea pigs inoculated with EV71 vaccine at the designed clinical dosage, which provided an experimental basis for phase Ⅰ clinical trial on EV71 vaccine.

关 键 词：肠道病毒71疫苗 临床前安全性评价 过敏性反应 

分 类 号：R373.2[医药卫生—病原生物学] R392-33[医药卫生—基础医学]