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Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01E-4 tuberculosis vaccine.

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Title: Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01E-4 tuberculosis vaccine.
Authors: Dagnew AF; Gates Medical Research Institute, Cambridge, MA, USA. Electronic address: alemnew.dagnew@gatesmri.org., Noble R; Gates Medical Research Institute, Cambridge, MA, USA., Cinar A; Gates Medical Research Institute, Cambridge, MA, USA., Burhan E; Pulmonary Mycosis Centre, Jakarta, Indonesia; Department of Pulmonology and Respiratory Medicine, Faculty of Medicine Universitas Indonesia - Persahabatan Hospital, Jakarta, Indonesia; Respiratory Programmatic Implementation and Research Institute, Jakarta, Indonesia., Churchyard G; Aurum Institute, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa., Fairlie L; Wits RHI, University of Witwatersrand, Johannesburg, South Africa., Hanekom WA; Africa Health Research Institute, KwaZulu-Natal, South Africa., Muyoyeta M; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia., Mwandumba HC; Malawi Liverpool Wellcome Research Programme, Kamuzu University of Health Sciences, Blantyre, Malawi; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK., Nduba V; Kenya Medical Research Institute, Centre for Respiratory Diseases Research (CRDR), Nairobi, Kenya., Curran M; Gates Medical Research Institute, Cambridge, MA, USA., Schmidt AC; Gates Medical Research Institute, Cambridge, MA, USA.
Source: Vaccine [Vaccine] 2026 Jul 11; Vol. 85, pp. 128690. Date of Electronic Publication: 2026 May 12.
Publication Type: Clinical Trial Protocol; Journal Article
Journal Info: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01<subscript>E-4</subscript> tuberculosis vaccine.
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  Data: <searchLink fieldCode="AU" term="%22Dagnew+AF%22">Dagnew AF</searchLink>; Gates Medical Research Institute, Cambridge, MA, USA. Electronic address: alemnew.dagnew@gatesmri.org.<br /><searchLink fieldCode="AU" term="%22Noble+R%22">Noble R</searchLink>; Gates Medical Research Institute, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Cinar+A%22">Cinar A</searchLink>; Gates Medical Research Institute, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Burhan+E%22">Burhan E</searchLink>; Pulmonary Mycosis Centre, Jakarta, Indonesia; Department of Pulmonology and Respiratory Medicine, Faculty of Medicine Universitas Indonesia - Persahabatan Hospital, Jakarta, Indonesia; Respiratory Programmatic Implementation and Research Institute, Jakarta, Indonesia.<br /><searchLink fieldCode="AU" term="%22Churchyard+G%22">Churchyard G</searchLink>; Aurum Institute, Johannesburg, South Africa; Department of Medicine, Vanderbilt University, Nashville, TN, USA; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Fairlie+L%22">Fairlie L</searchLink>; Wits RHI, University of Witwatersrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Hanekom+WA%22">Hanekom WA</searchLink>; Africa Health Research Institute, KwaZulu-Natal, South Africa.<br /><searchLink fieldCode="AU" term="%22Muyoyeta+M%22">Muyoyeta M</searchLink>; Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.<br /><searchLink fieldCode="AU" term="%22Mwandumba+HC%22">Mwandumba HC</searchLink>; Malawi Liverpool Wellcome Research Programme, Kamuzu University of Health Sciences, Blantyre, Malawi; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.<br /><searchLink fieldCode="AU" term="%22Nduba+V%22">Nduba V</searchLink>; Kenya Medical Research Institute, Centre for Respiratory Diseases Research (CRDR), Nairobi, Kenya.<br /><searchLink fieldCode="AU" term="%22Curran+M%22">Curran M</searchLink>; Gates Medical Research Institute, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Schmidt+AC%22">Schmidt AC</searchLink>; Gates Medical Research Institute, Cambridge, MA, USA.
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  Data: <searchLink fieldCode="JN" term="%228406899%22">Vaccine</searchLink> [Vaccine] 2026 Jul 11; Vol. 85, pp. 128690. <i>Date of Electronic Publication: </i>2026 May 12.
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  Data: Clinical Trial Protocol; Journal Article
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8406899 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-2518 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%220264410X%22">0264410X </searchLink><i>NLM ISO Abbreviation: </i>Vaccine <i>Subsets: </i>MEDLINE
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              Text: 2026 Jul 11
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