【摘要】 卡介苗作为目前唯一批准使用的预防结核疫苗,由于无法提供充足的保护力,目前结核病依然是严重危害人类健康的传染病,因此筛选优质候选疫苗迫在眉睫。所有候选疫苗进入临床试验前必须评价其安全性、免疫原性以及有效性。评价结果在一定程度上也预示候选疫苗在人体的免疫作用,也是目前评价候选疫苗是否优于传统卡介苗的依据。论述候选结核疫苗临床试验前所使用的体内和体外评价模型。对评价模型的充分认识将提高候选疫苗评价数据对人体临床试验的预测意义,也可更具体地执行实验动物的替代、减少和优化原则。更多还原

【Abstract】 Bacille Calmette-Guerin(BCG) vaccine as the only licensed vaccine cannot provide sufficient protection against tuberculosis, and tuberculosis is still a vital threat to public health, therefore, screening a prime quality tuberculosis vaccine is imminent. Models evaluations are essential tools to evaluate the safety, immunogenicity and efficacy of all candidate vaccines before entering clinical trials. And the evaluation results also predicted the immunity of candidate vaccine in human body to a certain extent, and it is also a foundation whether the present evaluation candidate vaccine excelled the traditional BCG. This paper discourses the evaluation models of candidate tuberculosis vaccines before the clinical trail that used in vivo and in vitro. The thorough understanding of evaluation models will improve the evaluation data of the candidate vaccines with predictive significance for clinical trials in human body, also can be implemented by the principles of replacement, reduction and optimization in the use of experimental animals.更多还原