Review of the current TB human infection studies for use in accelerating TB vaccine development: A meeting report

Balasingam, Shobana, Dheda, Keertan, Fortune, Sarah, Gordon, Stephen, Hoft, Daniel, Kublin, James G, Loynachan, Colleen N, McShane, Helen, Morton, Ben ORCID: https://orcid.org/0000-0002-6164-2854, Nambiar, Sujatha, Sharma, Nimisha Raj, Robertson, Brian, Schrager, Lewis K and Weller, Charlotte L (2024) 'Review of the current TB human infection studies for use in accelerating TB vaccine development: A meeting report'. Journal of Infectious Disease, Vol 230, Issue 2, e457-e464.

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Abstract

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.

Item Type:	Article
Subjects:	QW Microbiology and Immunology > Immunotherapy and Hypersensitivity > QW 806 Vaccination WA Public Health > Preventive Medicine > WA 115 Immunization WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1093/infdis/jiae238
Depositing User:	Leah Dempsey
Date Deposited:	22 May 2024 11:01
Last Modified:	03 Sep 2024 14:13
URI:	https://archive.lstmed.ac.uk/id/eprint/24550

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