Pre-Clinical Models & Biomarker Discovery, Aeras, Rockville, Maryland, USA.
Vir Biotechnology, San Francisco, California, USA.
Infect Immun. 2018 Jan 22;86(2). doi: 10.1128/IAI.00776-17. Print 2018 Feb.
Clinical trials of novel tuberculosis (TB) vaccines are expensive, while global resources for TB vaccine development are limited. Therefore, there is a need for robust and predictive preclinical data to support advancement of candidate vaccines into clinical trials. Here, we provide a rationale for using the nonhuman primate as an essential component of these efforts, as well as guidance to the TB community for standardizing experimental design and aligning endpoints to facilitate development of new TB vaccines.
新型结核病 (TB) 疫苗的临床试验费用高昂,而全球结核病疫苗研发资源有限。因此,需要有强大且可预测的临床前数据来支持候选疫苗进入临床试验。在这里,我们提供了将非人类灵长类动物作为这些努力的重要组成部分的基本原理,以及为结核病研究界提供了指导,以标准化实验设计并协调终点,从而促进新的结核病疫苗的开发。