About

Clinical development

MTBVAC AVANTE is supporting two major ongoing clinical trials that are designed to generate robust evidence on the safety, immunogenicity and efficacy of MTBVAC across key target populations.

IMAGINE Trial

Purpose
The IAVI-sponsored phase 2b IMAGINE clinical trial (NCT06272812) is evaluating the safety and efficacy of MTBVAC to prevent active lung disease in adolescents and adults living in regions with a high TB burden.
Timeline
February 2025 – March 2028		Study setting
15 clinical research center (CRC) partners in South Africa, Kenya, and Tanzania.
Participants
Approximately 5,500 adolescents and adults aged 14-45 years:
  • 4,300 participants with prior Mtb exposure (IGRA-positive) but without TB disease
  • 1,200 Mtb-unexposed (IGRA-negative) participants
Key endpoints
Efficacy, safety, and immunogenicity
Activities under MTBVAC AVANTE
  • Co-funding an additional cohort to assess safety and immunogenicity among 1,200 Mtb-unexposed participants, which began enrolment in February 2026 under an earlier grant from Coefficient Giving.
  • MTBVAC AVANTE will also support the biobanking samples from participants for future analysis.

MTBVACN3 Trial

Purpose
The Biofabri-sponsored phase 3 MTBVACN3 clinical trial (NCT04975178) is evaluating the efficacy and safety of MTBVAC compared to BCG in preventing TB disease in newborns in regions with a high TB burden.
Timeline
October 2022 – February 2029		Study setting
Five CRCs in South Africa, Senegal, and Madagascar
Participants
More than 7,000 newborns born to mothers living with and without HIV		Key endpoints
Efficacy, safety, and immunogenicity
Activities under MTBVAC AVANTE
  • Support the successful conclusion of the trial, as well as biobanking samples from participants for future analysis.

Clinical trials overview

TrialPopulationPrimary focus
IMAGINE Phase 2b (NCT06272812)Adolescents and adultsEfficacy, safety, and immunogenicity
MTBVACN3 Phase 3 (NCT04975178)NewbornsEfficacy, safety, and immunogenicity