Immunization With BCG Vaccine to Prevent Tuberculosis Infection
Public ClinicalTrials.gov record NCT04453293. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Proof-of Concept, Randomized, Controlled Study of Tuberculosis Immunization With BCG to Prevent Infection in Healthy Adults (TIPI Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04453293
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2021
- Primary completion
- Jan 15, 2026
- Completion
- Jan 15, 2026
- Last update posted
- Jan 22, 2026
2021 – 2026
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| MedStar Washington Hospital Center/MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| Hope Clinic of the Emory University Vaccine Center, Emory University | Decatur | Georgia | 30030 | — |
| Johns Hopkins Bloomberg School of Public Health, Department of International Health, Center for Immunization Research | Baltimore | Maryland | 21205 | — |
| The Brigham and Women's Hospital Center for Clinical Investigation | Boston | Massachusetts | 02115 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Tuberculosis Infection trials
Other public records listing Tuberculosis Infection. Sorted by last update posted; newest first. Not a recommendation.
- NCT05766267: Short-course Regimens for the Treatment of Pulmonary Tuberculosis Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04453293, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04453293 live on ClinicalTrials.gov.