Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

Phase 3

Active, not recruiting

• Conditions: Tuberculosis
• Interventions: Biological: Placebo; Biological: M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine

• Registration Number: NCT06062238
• Lead Sponsor: Gates Medical Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Study Start: 2024-03-05
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-21
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20081

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving placebo	Placebo	-
Participants receiving M72/AS01E-4	M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
HIV Cohort: Number of participants with laboratory-confirmed pulmonary TB	Up to Month 49
IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary TB (Less stringent laboratory-confirmed pulmonary TB case definition)	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 at least 1 positive Mtb culture or at least 1 positive 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.; Compose
All Cohorts: Number of participants with serious adverse events (SAEs)	Up to Month 13
IGRA-Negative Cohort: Number of participants with sustained QuantiFERON®-TB Gold Plus assay conversion	Up to Month 49
All Cohorts: Number of participants with potential immunemediated diseases (pIMDs)	Up to Month 13
All Cohorts: Number of participants with SAEs related to trial participation	Up to Month 49
All Cohorts: Number of participants with unsolicited AEs	Up to 28 days
IGRA-Negative Cohort: Number of participants with laboratory-confirmed pulmonary TB	Up to Month 49
All cohorts: Number of participants with seropositivity of M72-specific antibodies	At Day 1, Month 1, Month 2, Month 7, Month 13, Month 37, and Month 49
All Cohorts: Number of participants with solicited adverse events (AEs)	Up to 7 days
All cohorts: Number of participants with geometric mean concentration (GMC) of M72-specific antibodies	At Day 1, Month 1, Month 2, Month 7, Month 13, Month 37, and Month 49

Trial Locations

Locations (54)

2201-Gates MRI Investigational Site; 🇮🇩 Bandung, Indonesia

2204-Gates MRI Investigational Site; 🇮🇩 Depok, Indonesia

2202-Gates MRI Investigational Site; 🇮🇩 Jakarta, Indonesia

2205-Gates MRI Investigational Site; 🇮🇩 Jakarta, Indonesia

2203-Gates MRI Investigational Site; 🇮🇩 Jakarta, Indonesia

1205-Gates MRI Investigational Site; 🇰🇪 Eldoret, Kenya

1203-Gates MRI Investigational Site; 🇰🇪 Homa Bay, Kenya

1206-Gates MRI Investigational Site; 🇰🇪 Kericho, Kenya

1207-Gates MRI Investigational Site; 🇰🇪 Kilifi, Kenya

1202-Gates MRI Investigational Site; 🇰🇪 Kisumu, Kenya

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