MedTrace Logo

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

NCT07094711 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-06

No results posted yet for this study

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

Conditions

  • Mycobacterium Avium-intracellulare Infection
  • Mycobacterium Infections, Nontuberculous

Interventions

BIOLOGICAL

Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine

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.

DRUG

preservative-free saline

Patients randomized to the placebo arm will receive 0.1 mL preservative-free saline alone.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2028-09-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07094711 on ClinicalTrials.gov