Trials / Completed
CompletedNCT01317667
Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
Phase 1 Escalating, Multiple-Dose Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- U.S. Army Medical Research and Development Command · Federal
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RVEc |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-11-01
- Completion
- 2014-12-01
- First posted
- 2011-03-17
- Last updated
- 2020-01-03
- Results posted
- 2015-02-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01317667. Inclusion in this directory is not an endorsement.