A Phase 2 interventional study of Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine and preservative-free saline in Mycobacterium Avium-intracellulare Infection and Mycobacterium Infections, Nontuberculous, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
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:
Mycobacterium avium complex (MAC) lung disease (LD) is an increasingly prevalent condition in the United States. Treatment involves administration of multiple antibiotics for at least 12 months and many patients still fail, or infection recurs. New therapeutic strategies are needed. We hypothesize that Mycobacterium bovis Bacillus Calmette Guerin (BCG) will have microbiologic activity against MAC during lung disease, because of
Objectives:
The primary objective is to determine the safety and immunogenicity of BCG against MAC lung disease after intradermal vaccination with BCG or placebo.
The secondary objectives include:
Endpoints:
Primary endpoints:
Secondary endpoints:
Exploratory endpoints:
Study Population:
We aim to enroll a total of 48 participants with MAC, of which 24 will be randomized to receive each of BCG and placebo.
72 studies on the registry are indexed under Mycobacterium avium-intracellulare Infection; 8 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 46 interventional studies indexed under Mycobacterium avium-intracellulare Infection.
Browse Mycobacterium avium-intracellulare Infection studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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:
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:
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:
Biological/Vaccine: Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine
Biological: Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine
preservative-free saline
Drug: preservative-free saline
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.
Also known as: TICE® BCG
Patients randomized to the placebo arm will receive 0.1 mL preservative-free saline alone.
Also known as: saline
Adverse events
Safety and tolerability of intradermal BCG (TICE®) in this patient population, compared to placebo, assessed by weekly questionnaire of adverse events. Licensed study team member will follow-up on any events reported to be more than mild. Follow-up will be completed as a telemedicine or in person visit
Time frame: 12 weeks after intervention
Serious adverse events
Serious adverse events related to the intradermal BCG over 12 months after intervention.
Time frame: 12 months
Immunogenicity
Compare changes in immunogenicity, as measured by IFN-gamma production between the BCG and placebo groups. We will assess for increases in T cell immune responses against BCG and MAC, as measured by cytokine production, in those who received the BCG vaccine and those that received placebo. We will use ex vivo T cell stimulation assays to quantify the antigen specific T cell responses and assess cytokine production via flow cytometry and/or multiplexed enzyme-linked immunosorbent assay (Luminex).
Time frame: 24 months
Sputum cultures
Compare proportion of sputum cultures positive for MAC between the two groups
Time frame: 24 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 2 years after the publication date of the primary endpoint by contacting Dr. Houpt. No protected health information will be shared.
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