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NCT05592223 · ClinicalTrials.gov registry record · Phase 1
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT05592223: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT05592223 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05592223, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial replication as a method of assessing antimycobacterial agents and/or protective immunity elicited by vaccines or host-directed therapy. The trial will illuminate the nature of local and systemic immune responses to BCG and treatment response, as well as demonstrate our local capacity for newer, more innovative study designs.
Primary Outcome
Through microbial culture, quantify in colony forming units (CFU) BCG bacterial burden in skin biopsies from challenge sites. Outcome measure if the mean cfu from day 15 biopsy specimens.
Interventions
- DRUG Rifampin
- DRUG Isoniazid
- DRUG BCG Vaccine USP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT05592223 record still lists
NCT05592223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT05592223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05592223 about?
NCT05592223 is a clinical study titled "Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines". The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial replication as a method of assessing antimycobacterial agents and/or protective...
What is the current status of trial NCT05592223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-12-06. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT05592223?
The interventions under investigation include: Rifampin (DRUG), Isoniazid (DRUG), BCG Vaccine USP (DRUG).
Who is sponsoring clinical trial NCT05592223?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05592223's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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