At a glance
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A Phase I Single Site Open Label Clinical Trial for the Development of a Human BCG Challenge Model to Assess TB Drugs and Vaccines.
In Brief
A Phase 1 clinical trial evaluating BCG Vaccine USP, Isoniazid, and 1 other intervention for Tuberculosis. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
2x10\^6 cfu Tice® BCG (ID)
INH in the dose of 300 mg for three days post BCG injection.
RIF in the dose of 600 mg for seven days post BCG injection.