NCT05947890

Evaluating the Safety and Immunogenicity of MTBVAC

A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

Detailed description

This study will evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa. The study will be conducted in two parts (Part A and B). Part A will include two Cohorts (Cohort 1 and 2) and each Cohort will have four groups. Part B will have one Cohort which will also have four groups. Participants will be recruited into three cohorts (Cohorts 1-3) based on their HIV status and, for People Living With HIV, their CD4+ T cell count and WHO clinical stage prior to ART initiation/re-initiation. Within each cohort, they will be stratified into subgroups based on their IGRA status. For Cohorts 1 and 2 which will enroll simultaneously, participants will be randomized to receive MTBVAC or BCG according to the ratio of the planned sample sizes within the cohort; there is no placebo group in this trial. Enrollment of Cohort 3 will proceed if safety criteria are met for Cohorts 1 and 2, with randomization to MTBVAC and BCG. Participants in all groups will receive a single ID study product injection of 0.1 mL in volume and will be followed for 48 weeks.

Conditions

• HIV I Infection
• Tuberculosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-30
• Primary completion: 2027-04-05
• Completion: 2027-04-05
• First posted: 2023-07-17
• Last updated: 2026-03-12

Locations

16 sites across 1 country: South Africa