Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa

PHASE2RecruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

January 30, 2024

Primary Completion Date

February 2, 2026

Study Completion Date

February 2, 2026

Conditions
HIV I InfectionTuberculosis
Interventions
BIOLOGICAL

MTBVAC

The MTBVAC vaccine is a freeze-dried lyophilized pellet containing live attenuated strain MTBVAC01 derived from Mycobacterium tuberculosis (M.tb). Excipients include sucrose and sodium glutamate.

BIOLOGICAL

BCG

The active substance in BCG vaccine is a freeze-dried powder containing live attenuated Mycobacterium bovis BCG, Danish strain 1331 and sodium glutamate as a stabilizer. The powder is white and crystalline and may be difficult to see due to the small amount contained in each vial.

Trial Locations (16)

1862

RECRUITING

Soweto - Gauteng, Johannesburg

2092

RECRUITING

Johannesburg - CHRU, Westdene

4001

RECRUITING

Durban - Botha's Hill CRS, Durban

4052

RECRUITING

Durban - Wentworth, Durban

6850

RECRUITING

Worcester - SATVI, Worcester

7700

RECRUITING

Cape Town - UCTLI, Cape Town

7750

RECRUITING

Cape Town - Emavundleni, Cape Town

7784

RECRUITING

Cape Town - Groote Schuur, Cape Town

Unknown

RECRUITING

Cape Town - Khayelitsha, Cape Town

RECRUITING

Durban - Chatsworth, Chatsworth

NOT_YET_RECRUITING

Durban eThekwini, Durban

RECRUITING

Durban - Isipingo, Isipingo

RECRUITING

Klerksdorp, Klerksdorp

RECRUITING

Ladysmith, Ladysmith

RECRUITING

Rustenburg CRS, Rustenburg

RECRUITING

Soshanguve, Soshanguve

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Biofabri, S.L

INDUSTRY

lead

HIV Vaccine Trials Network

NETWORK