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RECRUITING
NCT06272812
PHASE2

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

Sponsor: International AIDS Vaccine Initiative

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

14 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

5500

Start Date

2025-02-19

Completion Date

2028-03-31

Last Updated

2026-03-31

Healthy Volunteers

Yes

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

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