M72/AS01E-4 Phase 3 Clinical Trial Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Assess the Prophylactic Efficacy, Safety, and Immunogenicity of the Investigational M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine When Administered Intramuscularly on a 0,1-month Schedule to Adolescents and Adults.

The first location is the clinical trial site at the University of the Witwatersrand, Johannesburg, South Africa. At total capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries: South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives the vaccine or placebo.

M72/AS01E-4 Phase 3 Clinical Trial Intervention

Biological: M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine. On Day 1 and Day 29, participants will receive an intramuscular dose of M72 (recombinant fusion protein) reconstituted with AS01E-4 (an adjuvant system).

M72/AS01E-4 Phase 3 Clinical Trial Primary Outcome Measures

IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary TB. Time Frame: Up to Month 61. Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weight loss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least two positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding "trace positive"), for at least 1 of the three sputum samples collected at three different visits, preferably within a 7-day time frame, before initiation of TB treatment.