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

NCT06062238 Phase 3 ACTIVE_NOT_RECRUITING

The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.

Details

Lead sponsor	Gates Medical Research Institute
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	20080
Start date	2024-03-05
Completion	2028-04

Conditions

• Tuberculosis

Interventions

• M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine
• Placebo

Primary outcomes

• IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB) — Up to Month 49
  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 least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding "trace positive"), from the same or from different sputum samples collected during the 3 suspected TB visits, preferably within a 7-day time frame, before initiation of TB treatment.

Countries

Indonesia, Kenya, Malawi, South Africa, Zambia