NCT02385825

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

Phase 1b Escalating Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) Administered Intramuscularly to Healthy Adults as a 3-Dose Primary Series and Booster

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ricin Poisoning

Interventions

Type	Name	Description
BIOLOGICAL	RVEc	The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin A-chain 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2015-03-11
• Last updated: 2020-01-02

Locations

1 site across 1 country: United States