Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04453293 · ClinicalTrials.gov registry record · Phase 3
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
A Phase 3 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Terminated
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT04453293: Clinical Trial Phase 3 study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT04453293 is a Phase 3 study that was terminated before completion, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04453293, a Phase 3 study, was terminated before completion, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
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.
Primary Outcome
Conversion change of TB IGRA from pre-travel baseline value of negative to positive post-travel, using FDA-approved breakpoints as a measure of Mycobacterium tuberculosis infection. Response will be assessed using technology of the T-SPOT.TB test method. Specifically, the test measures the number of spots from T cells sensitized to TB infection on a plate containing 4 different antigens: nil (negative control), 2 TB antigens (ESAT-6 and CFP-10, also called Panel A and Panel B), and phytohemagglu
Interventions
- DRUG Placebo
- BIOLOGICAL BCG (Tokyo 172) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2026-01-16 |
| Phase | Phase 3 |
Why NCT04453293 stopped before completion
NCT04453293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04453293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04453293 about?
NCT04453293 is a clinical study titled "Immunization With BCG Vaccine to Prevent Tuberculosis Infection". 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 va...
What is the current status of trial NCT04453293?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2021-12-01. Estimated completion is 2026-01-16.
What interventions are being tested in trial NCT04453293?
The interventions under investigation include: Placebo (DRUG), BCG (Tokyo 172) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04453293?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04453293's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI