Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG in Patients With Mycobacterium Avium Complex Lung Disease (BOOST)

What this Trial Is About

Researchers are studying whether the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be safely used to treat Mycobacterium avium complex (MAC) lung disease. This condition is becoming more common and current treatments with multiple antibiotics for at least 12 months often fail or the infection returns. The study aims to compare the safety and immune responses between patients receiving BCG or a placebo, while also measuring the vaccine's impact on respiratory illness and lung infection over time. Participants will be randomly assigned to receive a single intradermal injection of either the BCG vaccine or a placebo made of preservative-free saline. The vaccine dose contains a small amount of weakened Mycobacterium bovis bacteria. The study includes an injection on Day 0, a visit on Day 60, and a final visit at the end of the study. The trial will assess safety and immune responses at 12 weeks and 12 months, while also monitoring sputum cultures and respiratory health over 24 months. During the study, participants will provide blood samples three times (on injection day, Day 60, and at the study's end) and complete surveys about their health. Monthly sputum samples will be collected as usual care. Researchers will track adverse events, immune responses, and lung health using questionnaires and sputum tests. Follow-up will continue for up to 24 months to monitor safety, vaccine effectiveness, and respiratory illness rates.

Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)