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NCT07094711 · ClinicalTrials.gov registry record · Phase 2
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
A Phase 2 study, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT07094711: Recruiting Phase 2 study, sponsored by University of Virginia.
NCT07094711 is a Phase 2 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094711, a Phase 2 study, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
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
Primary Outcome
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
Interventions
- BIOLOGICAL Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine
- DRUG preservative-free saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-04-27 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 2 |
What NCT07094711 shows while recruiting
NCT07094711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine is the first listed.
NCT07094711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07094711 about?
NCT07094711 is a clinical study titled "Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)". 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 placeb...
What is the current status of trial NCT07094711?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2026-04-27. Estimated completion is 2028-12-30.
What interventions are being tested in trial NCT07094711?
The interventions under investigation include: Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine (BIOLOGICAL), preservative-free saline (DRUG).
Who is sponsoring clinical trial NCT07094711?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07094711's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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