[Evaluation models and indicators considerations for assessing non-clinical animal protective efficacy of...

Tuberculosis represents a significant challenge to global public health. The protective efficacy of the currently available Bacille Calmette-Guérin (BCG) vaccine is limited, highlighting the urgent need for advancements in the research and development of novel vaccines. Non-clinical evaluation of protective efficacy constitutes a critical component of vaccine development. To ensure the quality of preclinical assessments, it is essential to establish a standardized model. This article comprehensively examines the key factors involved in evaluating the non-clinical protective efficacy of tuberculosis vaccines, proposes a hierarchical evaluation strategy for animal models, and recommends incorporating both laboratory strains such as H37Rv and dominant field strains, including the prevalent Beijing family strain in China, to optimize infection model parameters. With regard to evaluation metrics, the article emphasizes the importance of constructing a multi-dimensional analytical framework that integrates immunogenicity, pathological features, and etiological bacterial load. This article aims to provide a robust scientific foundation for enhancing the quality of tuberculosis vaccine research and development, as well as facilitating the clinical translation of vaccine studies.