Clinical Trials | Do you have MAC lung disease?
Safety, immunogenicity, and efficacy of therapeutic Mycobacterium bovis BCG vaccination in patients with Mycobacterium avium complex lung disease (BOOST).
The Infectious Disease Department seeks men and women 18 years and older with MAC (Mycobacterium avium complex) lung disease for a research study called BOOST. The purpose of the study is to find out if Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine is safe and if it helps the body's immune system protect against MAC lung disease. Participants will receive either the TICE® BCG vaccine or a placebo (a harmless substance that looks like the study drug, but which should have no effect) by injection (given into the skin) and researchers will compare the results between the two groups. You may be eligible for this study if: 1. Diagnosed with or have been treated for MAC lung disease. 2. Medical records show evidence of MAC lung disease (positive tests, symptoms, and lung imaging findings). 3. You are willing to follow all study procedures. 4. Women who can become pregnant must use a highly effective birth control method during the study and for 90 days after receiving the study injection. Study involves: 1. 3 in-person visits, the first visit will last up to 4 hours, then up to 1 hour for the other visits. Telemedicine/Phone (remote) as needed or if required. Total participation is up to 2 years. 2. Tests such as a physical exam, blood draws, and a pregnancy test(if applicable). 3. Study drug injection (placebo or BCG) at the first visit. 4. Answer questionnaires (weekly for 12 weeks, then monthly for up to 2 years) 5. Study-related sputum kits provided at no cost. You can receive up to $550 for completing the entire 2-year study. You will be paid $25 for each follow-up that includes a monthly sputum sample (from Month 2 through Month 24). Additional details about the study may be found https://clinicaltrials.gov/study/NCT07094711 Contact Name: MAC Lung Disease Group Contact Email: [email protected] Contact Phone: 434-243-4008