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Immunization With BCG Vaccine to Prevent Tuberculosis Infection

NCT04453293 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Tuberculosis Infection

Interventions

BIOLOGICAL

BCG (Tokyo 172) vaccine

Freeze-Dried Glutamate Bacillus Calmette-Guérin BCG Vaccine (Japan BCG Laboratory), 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region

DRUG

Placebo

Placebo vaccine diluent, 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Naomi E. Aronson, MD · Uniformed Services University of the Health Sciences

  • Merlin L. Robb, MD · Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-01-16
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04453293 on ClinicalTrials.gov