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

NCT02385825 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-01-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Phillip R Pittman, MD, MPH · US Army Medical Research Institute of Infectious Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385825 on ClinicalTrials.gov