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DAR-901 is an inactivated whole-cell mycobacterial vaccine candidate developed for the prevention of tuberculosis (TB), specifically as a booster for individuals previously primed with the Bacillus Calmette-Guérin (BCG) vaccine. It is manufactured using a scalable broth-grown process from the master cell bank of SRL-172, a vaccine derived from *Mycobacterium obuense* that previously demonstrated efficacy in a Phase 3 trial (the DarDar trial). DAR-901 aims to induce broad, cross-reactive cellular and humoral immune responses against *Mycobacterium tuberculosis*. While a Phase 2b trial in Tanzanian adolescents did not meet its primary endpoint of preventing initial TB infection (IGRA conversion), the vaccine was found to be safe and well-tolerated, and it induced enhanced immune responses to specific TB antigens, supporting further investigation for the prevention of TB disease.
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