Wei Jiazheng, Li Junli, Li Xiaochi, Du Weixin, Su Cheng, Sheng Xiaobing, Huang Yang, Wang Jinsong, Niu Qun, Chen Guoqing, Tian Wei, Zhao Aihua, Xu Miao
College of Life Sciences and Biopharmaceuticals, Shenyang Pharmaceutical University, Shenyang 117004, China.
Division of Tuberculosis Vaccine and Allergen Products, Institute of Biological Product Control, National Institutes for Food and Drug Control, Beijing 102629, China.
Vaccines (Basel). 2025 Jun 21;13(7):669. doi: 10.3390/vaccines13070669.
Tuberculosis (TB) remains one of the most significant challenges to global public health. Vaccine development is a critical strategy for the prevention and control of TB. However, evaluating the protective efficacy of TB vaccines faces numerous challenges, particularly in the selection of animal models and bacterial strains. Variations in animal models, challenge strains, challenge routes, and doses can significantly impact the outcomes of preclinical evaluations. This article highlights the importance of standardizing preclinical evaluation models, summarizes the animal models and challenge strains used in novel TB vaccine candidates, efficacy studies, and discusses the advantages and limitations of commonly used animal models in TB vaccine research. It also points out the differential performance of various animal models in simulating protection and pathology. Given the current limitations of using a narrow range of challenge strains and the lack of standardized infection routes and doses, this article calls for the establishment of more standardized challenge strains and the development of standardized evaluation models to improve the reliability and generalizability of new TB vaccine efficacy assessments.
结核病（TB）仍然是全球公共卫生面临的最重大挑战之一。疫苗研发是预防和控制结核病的关键策略。然而，评估结核病疫苗的保护效力面临诸多挑战，尤其是在动物模型和细菌菌株的选择方面。动物模型、攻击菌株、攻击途径和剂量的差异会显著影响临床前评估的结果。本文强调了标准化临床前评估模型的重要性，总结了新型结核病候选疫苗效力研究中使用的动物模型和攻击菌株，并讨论了结核病疫苗研究中常用动物模型的优缺点。文章还指出了各种动物模型在模拟保护和病理方面的不同表现。鉴于目前使用的攻击菌株范围狭窄以及缺乏标准化的感染途径和剂量的局限性，本文呼吁建立更标准化的攻击菌株并开发标准化评估模型，以提高新型结核病疫苗效力评估的可靠性和可推广性。
