Tools to evaluate and accelerate tuberculosis (TB) vaccine development are needed to advance global TB control strategies. Validated human infection studies for TB have the potential to facilitate breakthroughs in understanding disease pathogenesis, identify correlates of protection, develop diagnostic tools, and accelerate and de-risk vaccine and drug development. However, key challenges remain for realizing the clinical utility of these models, which require further discussion and alignment amongst key stakeholders. In March 2023, the Wellcome Trust and the International AIDS Vaccine Initiative (IAVI) convened international experts involved in developing both TB and Bacillus Calmette-Guerin (BCG) human infection studies (including mucosal and intradermal challenge routes) to discuss the status of each of the models and the key enablers to move the field forward. This report provides a summary of the presentations and discussion from the meeting. Discussions identified key issues, including demonstrating model validity, to provide confidence for vaccine developers, which may be addressed through demonstration of known vaccine effects, e.g. BCG vaccination in specific populations, and by comparing results from field efficacy and human infection studies. The workshop underscored the importance of establishing safe and acceptable studies in high-burden settings, and the need to validate more than one model to allow for different scientific questions to be addressed as well as to provide confidence to vaccine developers and regulators around use of human infection study data in vaccine development and licensure pathways.

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回顾当前用于加速结核病疫苗开发的结核病人类感染研究：会议报告

需要评估和加速结核病 (TB) 疫苗开发的工具来推进全球结核病控制战略。经过验证的人类结核病感染研究有可能促进疾病发病机制的突破，确定保护的相关性，开发诊断工具，并加速和降低疫苗和药物的开发风险。然而，实现这些模型的临床实用性仍然存在关键挑战，这需要主要利益相关者之间的进一步讨论和协调。 2023 年 3 月，威康信托基金会和国际艾滋病疫苗倡议 (IAVI) 召集了参与开展结核病和卡介苗 (BCG) 人类感染研究（包括粘膜和皮内攻击途径）的国际专家，讨论了各自的状况推动该领域向前发展的模型和关键推动因素。本报告总结了会议的发言和讨论。讨论确定了关键问题，包括证明模型的有效性，为疫苗开发人员提供信心，这可以通过证明已知的疫苗效果（例如在特定人群中接种卡介苗）以及比较现场功效和人类感染研究的结果来解决。研讨会强调了在高负担环境中建立安全和可接受的研究的重要性，以及验证多个模型的必要性，以解决不同的科学问题，并为疫苗开发商和监管机构提供关于人类使用疫苗的信心。疫苗开发和许可途径中的感染研究数据。