drugset / Trial / NCT02385825
IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost
Phase 1
Withdrawn
U.S. Army Medical Research and Development Command
US Army Medical Research Institute of Infectious Diseases · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event (AE) data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients.
Timeline
- Start
- 2016-04
- Primary completion
- 2017-06
- Completion
- 2017-12
Outcome
Outcome not reported
Stopped (Business): “lack of funding”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RVEc | Vaccine | 10 ug | Intramuscular |
| Subject | RVEc | Vaccine | 50 ug | Intramuscular |
| Subject | RVEc | Vaccine | 75 ug | Intramuscular |