{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T20:29:02Z","timestamp":1775852942539,"version":"3.50.1"},"reference-count":47,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T00:00:00Z","timestamp":1714953600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>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 among key stakeholders. In March 2023, the Wellcome Trust and the International AIDS Vaccine Initiative convened international experts involved in developing both TB and bacillus Calmette-Gu\u00e9rin (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 (eg, 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 &amp;gt;1 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.<\/jats:p>","DOI":"10.1093\/infdis\/jiae238","type":"journal-article","created":{"date-parts":[[2024,5,6]],"date-time":"2024-05-06T17:27:29Z","timestamp":1715016449000},"page":"e457-e464","source":"Crossref","is-referenced-by-count":9,"title":["Review of Current Tuberculosis Human Infection Studies for Use in Accelerating Tuberculosis Vaccine Development: A Meeting Report"],"prefix":"10.1093","volume":"230","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8112-1813","authenticated-orcid":false,"given":"Shobana","family":"Balasingam","sequence":"first","affiliation":[{"name":"Infectious Disease, Wellcome Trust , London , United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keertan","family":"Dheda","sequence":"additional","affiliation":[{"name":"Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town (UCT) Lung Institute and South African Medical Research Council\/UCT Centre for the Study of Antimicrobial Resistance, University of Cape Town , South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Fortune","sequence":"additional","affiliation":[{"name":"Department of Immunology and Infectious Diseases, Harvard T. 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Chan School of Public Health , Boston, Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen B","family":"Gordon","sequence":"additional","affiliation":[{"name":"Clinical Experimental Medicine, Malawi Liverpool Wellcome Programme , Blantyre"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Hoft","sequence":"additional","affiliation":[{"name":"Departments of Internal Medicine and Molecular Microbiology & Immunology, Saint Louis University of Medicine, Missouri"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James G","family":"Kublin","sequence":"additional","affiliation":[{"name":"Cancer Center, Vaccine and Infectious Disease Division, Fred Hutchinson Institute , Seattle, Washington"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colleen N","family":"Loynachan","sequence":"additional","affiliation":[{"name":"Infectious Disease, Wellcome Trust , London , United 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