IAVI Announces Enrollment of Cohort of People Without TB Infection in Phase 2b Trial of TB Vaccine Candidate MTBVAC

23 February 2026

IAVI announcement

IAVI announced the first vaccination administered in a new cohort of participants in the IMAGINE clinical trial of the TB vaccine candidate MTBVAC. This cohort will enroll 1,200 participants who have never been exposed to Mycobacterium tuberculosis (M.tb). Individuals in this new cohort will have a negative Interferon Gamma Release Assay (IGRA) blood test that measures immune memory to M.tb. Enrollment will take place at 16 clinical research centers in South Africa, Kenya, and Tanzania.

The IMAGINE trial is a Phase 2b, large-scale efficacy trial that will test the safety and immunogenicity of MTBVAC in adults and adolescents.

MTBVAC is a single-shot vaccine delivered via intradermal delivery. It does not require an adjuvant and is well-suited for use in difficult-to-reach locations. It is the only live-attenuated TB vaccine candidate derived from M.tb in current trials. This is a notable difference from BCG, the only approved TB vaccine, which is derived from Mycobacterium bovis.

Read the full announcement here.

Source: IAVI