TerminatedPhase 3

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

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

United States16 participantsStarted 2021-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Participant is willing to participate in the study as evidenced by providing voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to conducting any trial related procedures
✓. Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent
✓. Participant is in good general health, confirmed by medical history, laboratory screening, and physical examination
✓. Participant has no known history of Mtb infection
✓. Participant has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine
✓. Participant is assessed to be at risk for TB exposure (particularly drug resistant TB) during planned travel and has planned to work in high or moderate TB burden countries for a duration of a minimum of 10 days and not greater than 6 months for HCW
✓. Participant presents at least 4 weeks prior to travel departure
✓. Participant is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine

Exclusion criteria

What they're measuring

Change in TB IGRA blood test results from baseline pre-travel and post-travel return

Timeframe: At baseline, and 8-10 weeks post-travel return

Trial details

NCT IDNCT04453293

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-16

View on ClinicalTrials.gov More Tuberculosis Infection trials