drugset
drugset / Trial / NCT04453293

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

NCT04453293 ↗

Phase 3 Terminated 16 enrolled Henry M. Jackson Foundation for the Advancement of Military Medicine Uniformed Services University of the Health Sciences · collabUnited States Department of Defense · collab
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled.

Timeline

Start
2021-12-01
Primary completion
2026-01-16
Completion
2026-01-16

Outcome

Outcome not reported

Stopped (Enrollment): “The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Calmette-Guérin Vaccine 0.1 ml Other

Indications

tuberculosis