Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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.