MedTrace Logo

Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

NCT05592223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

BCG Vaccine USP

2x10\^6 cfu Tice® BCG (ID)

DRUG

Isoniazid

INH in the dose of 300 mg for three days post BCG injection.

DRUG

Rifampin

RIF in the dose of 600 mg for seven days post BCG injection.

Sponsors & Collaborators

Principal Investigators

  • James Kublin, MD, MPH · Fred Hutchinson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2023-08-23
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592223 on ClinicalTrials.gov