NCT06272812View on ClinicalTrials.gov

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region.

PHASE2RecruitingINTERVENTIONAL
Enrollment

4,300

Participants

Timeline

Start Date

February 19, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
Tuberculosis (TB)
Interventions
BIOLOGICAL

MTBVAC

Vaccine Dose: MTBVAC 5x10\^5 Formulation (approximately, per standard dose): 3 - 17x10\^5 CFU Sucrose Sodium glutamate Presentation: Lyophilized pellet in vials (10 doses) Volume: 0.1 mL/dose Intradermal

BIOLOGICAL

Placebo

0.9% saline Volume: 0.1 mL/dose Intradermal

Trial Locations (1)

Unknown

RECRUITING

The Aurum Institute Tembisa Clinical Research Centre, Johannesburg

Sponsors

Collaborators (1)

Biofabri, SLU
All Listed Sponsors
collaborator

Biofabri, SLU

UNKNOWN

collaborator

Universidad de Zaragoza

OTHER

lead

International AIDS Vaccine Initiative

NETWORK

NCT06272812 - A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region. | Biotech Hunter | Biotech Hunter