drugset / Trial / NCT05592223
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-12-06
- Primary completion
- 2023-08-23
- Completion
- 2023-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isoniazid | Small molecule | 300 mg | Oral |
| Comparator | Rifampin | Small molecule | 600 mg | Oral |
| Comparator | BCG Vaccine USP | Vaccine | 2e+06 unknown | Other |