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NCT02063555 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of DAR-901
A Phase 1 study of Tuberculosis, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT02063555: Completed Phase 1 study of Tuberculosis, sponsored by Dartmouth-Hitchcock Medical Center.
NCT02063555 is a Phase 1 study of Tuberculosis that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 59 participants, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02063555, a Phase 1 study of Tuberculosis, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.
Primary Outcome
Subjects will be followed for both systemic side effects and injection site reactions
Conditions Studied
Interventions
- BIOLOGICAL BCG
- BIOLOGICAL DAR-901
- BIOLOGICAL Sterile saline
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02063555 record still lists
NCT02063555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 3 interventions - of which BCG is the first listed.
NCT02063555 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT02063555 about?
NCT02063555 is a clinical study titled "Phase I Trial of DAR-901". This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerab...
What is the current status of trial NCT02063555?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2014-02. Estimated completion is 2016-06.
What conditions does trial NCT02063555 study?
This clinical trial studies the following conditions: Tuberculosis.
What interventions are being tested in trial NCT02063555?
The interventions under investigation include: BCG (BIOLOGICAL), DAR-901 (BIOLOGICAL), Sterile saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT02063555?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02063555 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02063555's enrollment target sits among peer trials
59 22nd of 29 higher than 8 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis 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.
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