Actively Recruiting
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
Led by University of Virginia · Updated on 2026-05-06
48
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis or treatment for Mycobacterium avium complex lung disease confirmed by a pulmonologist or infectious disease physician
- History of at least 2 MAC positive respiratory cultures, with at least one within 1 year before enrollment (one culture if from bronchial lavage or biopsy)
- Respiratory or constitutional symptoms consistent with MAC lung disease
- Chest imaging showing nodular or cavitary opacities or bronchiectasis with multiple small nodules
- Signed and dated informed consent form
- Willingness to comply with all study procedures
- Women of childbearing potential agree to use highly effective birth control from Day 0 to 90 days after intervention
You will not qualify if you...
- Currently receiving antibiotics for MAC lung disease
- Received any antibacterial antibiotics within 14 days before study vaccination
- Allergy or intolerance to isoniazid, rifampin, or ethambutol
- Expected to start anti-MAC antibiotics within 2 months
- Congenital or acquired immune deficiencies, including HIV infection and recent cancer or immunosuppressive treatments
- Prior BCG vaccination
- Known pregnancy or breastfeeding at enrollment
- Diagnosis of cystic fibrosis
- Active tuberculosis or recent exposure to active pulmonary tuberculosis
- Hypersensitivity to BCG vaccine or its components
- Received live injectable vaccine within 28 days before study vaccination
- Any condition that may interfere with study results, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Health
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
E
Eric R Houpt, M.D.
CONTACT
T
Tania A Thomas, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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