CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 4 enrolled
Drug / intervention
50-μg booster dose 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.

Search/NCT01846104
NCT01846104Phase 1Completed

Safety and Immunogenicity of a Booster Dose (50 µg) of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Previously Vaccinated Healthy Adults

U.S. Army Medical Research and Development Command·interventional·Posted May 3, 2013·Updated Dec 27, 2019

In Brief

A Phase 1 clinical trial evaluating 50-μg booster dose RVEc for Ricin Poisoning. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg doses of RVEc in a Phase 1 trial (NCT01317667).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRicin Poisoning
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2013
Enrollment StartApr 30, 2013
Primary CompletionJun 30, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.2 years ago

Interventions

50-μg booster dose RVEcbiological

Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.