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
Description
ISSN:1873-2518
DOI:10.1016/j.vaccine.2026.128690