新型结核病疫苗及其评价方法的研究进展  

Progress in novel TB vaccine and related evaluation methods

作　　者：张怡田 王秉翔[1] 

机构地区：[1]兰州生物制品研究所有限责任公司第七研究室甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2016年第2期68-74,共7页Progress In Microbiology and Immunology

基　　金：十二五"重大新药创制"科技重大专项(项目编号:2013ZX09402302-225)

摘　　要：结核病是由结核分枝杆菌感染引起的慢性传染病,严重危害人类健康,卡介苗对儿童粟粒性结核和结核性脑膜炎保护效果较好,但对成人肺结核保护效果却不确定。过去十余年,众多研究人员一直致力于新型结核病疫苗的研发,但至今尚未成功。结核病的致病和免疫机制还不完全清楚,缺乏可以预测临床保护效果的指标和动物模型,动物实验结果常与临床试验结果不符,临床试验耗时漫长、成本昂贵、且需要大量结核病患者,这些都严重阻碍了结核病疫苗的研发。近年来,研究人员研发了一些新方法进行结核病疫苗临床前评价,从而缩短了进入临床试验的时间,加快了结核病疫苗的发展。综述了新型结核病疫苗的研究进展及其保护力评价方法,特别是临床前评价新方法。Tuberculosis remains a substantial global health problem due to the unsatisfactory effect of BCG. The global sustained development of novel TB vaccine has been processed in the past decade,but so far met with limited success. Pathogenesis and immunology of tuberculosis are not yet clearly understanding. Research and development of TB vaccine are hampered by the absence of validated correlates of immunity and animal models,the inconsistence of animal experiment and human challenge results,as well as by the size and cost of clinical trials. Innovative methods of preclinical evaluation are developed by scientists to shorten the time of entering the clinical trial and to accelerate the development of TB vaccine.This paper provides a summary of the novel TB vaccines and the evaluation method about protection of tuberculosis vaccine,especially the progress in the new preclinical evaluation.

关 键 词：结核病疫苗 效力评价 动物实验 MTB生长抑制试验 家兔皮肤液化 

分 类 号：R392[医药卫生—免疫学]