Could a 100-Year-Old TB vaccine help fight a tough lung infection?
NCT ID NCT07094711
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether the BCG vaccine, originally developed for tuberculosis, can safely treat Mycobacterium avium complex (MAC) lung disease. Researchers will give 48 adults either a single BCG injection or a placebo and monitor them for side effects, immune responses, and sputum cultures over 12 months. The goal is to see if BCG can boost the immune system to better control the infection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BCG vaccine (Bacillus Calmette-Guerin)
- What this could lead to
- If it works, this could point toward a new treatment option for MAC lung disease, a chronic infection that is hard to treat.
- What could go wrong
- This is a small, early-phase trial with only 48 participants. The BCG vaccine may not improve outcomes and could cause side effects like injection site reactions or flu-like symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female aged ≥18 years 2. Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician in the medical record. The following data will be extracted from the medical record: 1. History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from bronchial lavage or biopsy, one culture rather than 2 will meet criteria. 2. Respiratory and/or constitutional symptoms consistent with MAC lung disease 3. Nodular or cavitary opacities on chest radiograph or bronchiectasis with multiple small nodules on high-resolution computed tomography 3. Provision of signed and dated informed consent form 4. Stated willingness to comply with all study procedures 5. Women of childbearing potential (WOCBP) (i.e., fertile following menarche and until becoming postmenopausal unless permanently sterile) agree to practice a highly effective method of birth control from Day 0 to at least 90 days after study intervention. Some examples of acceptable birth controls are: 1. True abstinence (refraining from heterosexual intercourse during the entire study), 2. Copper intrauterine device (IUD), 3. Hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \[combined with barrier method\]), exclusive homosexual relationship) sole male partner who has undergone surgical sterilization Exclusion Criteria Selection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in this study: 1. Currently receiving antibiotics prescribed for their MAC lung disease 2. Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0 3. Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol 4. Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician 5. Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years; immunosuppressive therapy such as anti B cell depleting therapies, corticosteroids (\>20 mg/day for \> 14 days), dupilumab, elivaldogene, etrasimod, cytotoxic chemotherapy, miscellaneous oncologic agents, therapeutic immunosuppressant agents, methotrexate, teplizumab, tezepelumab, tildrakizumab, tralokinumab, ustekinumab). Persons with lung and other solid organ transplants/hematologic stem cell transplants who may be contraindicated to receive a live vaccine. Point of care HIV testing must be negative at baseline. 6. Prior BCG Vaccination. If unknown Bcgatlas.org shall be consulted for local vaccination administration policies. 7. Known pregnancy at the time of screening or breastfeeding at the time of enrollment (pregnancy test negative at baseline if applicable) 8. Cystic fibrosis 9. Active tuberculosis: Active tuberculosis (respiratory AFB culture growing Mycobacterium tuberculosis complex within the past 4 months). 10. Known exposure to a case of active pulmonary tuberculosis within 10 weeks of enrollment 11. Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine 12. Received live injectable vaccine within 28 days of day 0 study vaccination 13. Any condition in the opinion of the investigator that may confound the study endpoints Note that colonization or co-infection with other nontuberculous mycobacteria is not exclusionary, as MAC will be the endpoint.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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University of Virginia Health
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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