Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG in Patients With Mycobacterium Avium Complex Lung Disease (BOOST)
University of Virginia
48 participants
Apr 27, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease. Researchers will compare responses from patients with MAC lung disease after receiving an injection of BCG or placebo (a look-alike substance that contains no drug) Participants in the study: * Receive a BCG or placebo injection at UVA study center on Day 0 * Come to UVA study center on Day 60 * Come to UVA study center at the end of the study * Answer surveys and questionnaires about how you are doing * Have blood drawn 3 times, on injection day, day 60, and at end of study * Give the study team personal and demographic information * Discuss any new symptoms with the study team * Provide monthly sputum samples per usual care
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Subjects will be randomized to a single intradermal injection of BCG or placebo vaccine. Participants randomized to the BCG arm will receive TICE® BCG. Freeze-dried vaccine is produced in vials, each containing 1 to 8 x\^108 colony forming units (CFU). A vial will be reconstituted in 20 mL of preservative-free saline. Administration of 0.1 mL will contain \~2x\^106 CFU, which accounts for approximately 0.25 mg of the attenuated Mycobacterium bovis. Administration of 0.1 mL of diluted vaccine will be given per dose, intradermally.
Patients randomized to the placebo arm will receive 0.1 mL preservative-free saline alone.
Locations(1)
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NCT07094711