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RecruitingPhase 2NCT06272812

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

A Phase 2b, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine, MTBVAC, Against TB Disease in Adolescents and Adults Aged 14-45 Years, Living in a TB Endemic Region.

Sponsor

International AIDS Vaccine Initiative

Enrollment

5,500 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

Tuberculosis (TB)

Summary

A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.

Eligibility

Min Age: 14 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called MTBVAC and a biological treatment called Placebo for people with tuberculosis (tb). The study is currently recruiting participants at 16 locations. People eligible for this study include aged 14 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMTBVAC

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

BIOLOGICALPlacebo

0.9% saline Volume: 0.1 mL/dose Intradermal

Locations(16)

Victoria Biomedical Research Institute

Kisumu, Kenya

Kenya Medical Research Institute

Nairobi, Kenya

JOSHA Research

Bloemfontein, South Africa

South African Tuberculosis Vaccine Initiative

Cape Town, South Africa

TASK Applied Science Pty Ltd. TASK Delft

Cape Town, South Africa

UCTLI CLII - Centre for Lung Infection and Immunity

Cape Town, South Africa

University of Cape Town Lung Institute PtyLtd. Centre for Tuberculosis Research Innovation

Cape Town, South Africa

Wellcome Centre for Infectious Diseases Research in Africa

Cape Town, South Africa

Synergy Biomedical Research Institute

East London, South Africa

TASK Eden Pty Ltd.

George, South Africa

Perinatal HIV Research Unit

Johannesburg, South Africa

Be Part Research Pty Ltd.

Paarl, South Africa

The Aurum Institute Rustenburg Clinical Research Centre

Rustenburg, South Africa

Desmond Tutu Health Foundation, Masiphumelele Research Office

Sunnydale, South Africa

The Aurum Institute Tembisa Clinical Research Centre

Tembisa, South Africa

Ifakara Health Institute

Dar es Salaam, Tanzania

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NCT06272812

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