At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
RVEcbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
U.S. Army Medical Research and Development Command·interventional·Posted Mar 17, 2011·Updated Jan 3, 2020
In Brief
A Phase 1 clinical trial evaluating RVEc for Ricin. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionNov 2012
Study CompletionDec 2014
TodayJul 2026
First PostedMar 17, 2011
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.3 years ago
Interventions
RVEcbiological