drugset / Trial / NCT02385825

IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost

NCT02385825 ↗

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

EvaluationDrugModalityDoseRoute
Subject RVEc Vaccine 10 ug Intramuscular
Subject RVEc Vaccine 50 ug Intramuscular
Subject RVEc Vaccine 75 ug Intramuscular

Indications