Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)

Conditions

• Mycobacterium Avium-intracellulare Infection
• Mycobacterium Infections, Nontuberculous

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine — BIOLOGICAL
  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.
• preservative-free saline — DRUG
  Patients randomized to the placebo arm will receive 0.1 mL preservative-free saline alone.

Study Details

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

Key Dates

Start date

Apr 27, 2026

Status verified

May 2026

Primary completion

Sep 30, 2028

Completion

Dec 30, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active BCG
  Biological/Vaccine: Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine
• Placebo Comparator: Placebo
  preservative-free saline

Primary Outcome Measure

Adverse events [ Time Frame: 12 weeks after intervention ]

Central Contacts

• Eric R Houpt, M.D.
  +1 434 243 9326
  [email protected]
• Tania A Thomas, MD
  434-243-9592
  [email protected]

Locations (1)

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