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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria