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The discovery that BCG protects humans from becoming infected with\n                    <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                    (\n                    <jats:italic>Mtb<\/jats:italic>\n                    ) and not just from progressing to TB disease provides justification for considering\n                    <jats:italic>Mtb<\/jats:italic>\n                    infection as an endpoint in vaccine trials. Such trials would require fewer participants than those with disease as an endpoint. In this review, we first define\n                    <jats:italic>Mtb<\/jats:italic>\n                    infection and disease phenotypes that can be used for mechanistic studies and\/or endpoints for vaccine trials. Secondly, we review the evidence for BCG\u2010induced protection against\n                    <jats:italic>Mtb<\/jats:italic>\n                    infection from observational and BCG re\u2010vaccination studies, and discuss limitations and variation of this protection. Thirdly, we review possible underlying mechanisms for BCG efficacy against\n                    <jats:italic>Mtb<\/jats:italic>\n                    infection, including alternative T cell responses, antibody\u2010mediated protection, and innate immune mechanisms, with a specific focus on BCG\u2010induced trained immunity, which involves epigenetic and metabolic reprogramming of innate immune cells. Finally, we discuss the implications for further studies of BCG efficacy against\n                    <jats:italic>Mtb<\/jats:italic>\n                    infection, including for mechanistic research, and their relevance to the design and evaluation of new TB vaccines.\n                  <\/jats:p>","DOI":"10.1111\/imr.12965","type":"journal-article","created":{"date-parts":[[2021,3,12]],"date-time":"2021-03-12T04:46:46Z","timestamp":1615524406000},"page":"122-144","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":70,"title":["BCG\u2010induced protection against\n                    <i>Mycobacterium tuberculosis<\/i>\n                    infection: Evidence, mechanisms, and implications for next\u2010generation vaccines"],"prefix":"10.1111","volume":"301","author":[{"given":"Mitchell","family":"Foster","sequence":"first","affiliation":[{"name":"Department of Microbiology and Immunology University of Otago Dunedin New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7006-0549","authenticated-orcid":false,"given":"Philip C.","family":"Hill","sequence":"additional","affiliation":[{"name":"Centre for International Health University of Otago Dunedin New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todia Pediatama","family":"Setiabudiawan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI) Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie A. 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