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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 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05592223
The ClinicalTrials.gov registry entry for NCT05592223 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rifampin is the first listed.
NCT05592223 reports 0 study locations.
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.
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