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NCT01317667 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01317667 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 30 participants.
The verdict
NCT01317667, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine. The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.
Interventions
- BIOLOGICAL RVEc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317667
The ClinicalTrials.gov registry entry for NCT01317667 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RVEc is the first listed.
NCT01317667 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01317667 about?
NCT01317667 is a clinical study titled "Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)". This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine. The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elic...
What is the current status of trial NCT01317667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01317667?
The interventions under investigation include: RVEc (BIOLOGICAL).
Who is sponsoring clinical trial NCT01317667?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
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