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NCT01868464 · ClinicalTrials.gov registry record · Phase 1
Challenge Model for Assessment of Human TB Immunity
A Phase 1 study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT01868464 is a Phase 1 study of Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 92 participants, below the 931-participant average among 29 other Tuberculosis trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01868464, a Phase 1 study of Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the target population reflecting the community at 2 VTEU sites. Enrollment will occur over 14 months. Subjects who provide informed consent will be screened, and up to 120 eligible, HIV and TB uninfected subjects, 18-45 years, inclusive, will be enrolled for study interventions and sequentially assigned to 1 of 4 dose groups. Doses of Tice BCG from 2 to 16x10\^6 cfu will be delivered ID in a dose escalation format to 4 groups of 30 subjects per dose group. Primary Objectives: 1) Evaluate the safety of different doses of ID Tice BCG for use as a human challenge model for TB infection. 2) Examine shedding from ID challenge sites after administration of different doses of Tice BCG in TB naive healthy subjects. 3) Evaluate the reproducibility of BCG shedding over time with both quantitative PCR and culture.
Conditions Studied
Interventions
- BIOLOGICAL BCG TICE strain
Study Locations (2)
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2014-05-28 |
| Est. Completion | 2017-12-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01868464
The ClinicalTrials.gov registry entry for NCT01868464 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 931-participant average among 29 other Tuberculosis trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 1 intervention - of which BCG TICE strain is the first listed.
NCT01868464 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, Missouri.
Frequently Asked Questions
What is clinical trial NCT01868464 about?
NCT01868464 is a clinical study titled "Challenge Model for Assessment of Human TB Immunity". This is a Phase I open-label, dose escalation trial to evaluate the use of Tice® BCG as a challenge for future assessment of in vivo TB immunity. Subjects will be recruited from the target population reflecting the community at 2 VTEU sites. Enrollment will occur over 14 months. Subjects who provide...
What is the current status of trial NCT01868464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2014-05-28. Estimated completion is 2017-12-18.
What conditions does trial NCT01868464 study?
This clinical trial studies the following conditions: Tuberculosis.
What interventions are being tested in trial NCT01868464?
The interventions under investigation include: BCG TICE strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT01868464?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01868464 being conducted?
This trial has 2 study locations across Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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