Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin

Phase 1CompletedNCT00812071

University of Texas Southwestern Medical Center30 enrolled

Overview

Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.

Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RiVaxBIOLOGICAL

vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 31 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy volunteers aged 18-31, m or f Exclusion Criteria: * immunodeficiency * pregnant * chronic disease * parental IgG * abnormal labs * drug use * hiv * hep c * hep b

Locations (1)

Hampton Roads Center For Clinical Research

Chesapeake, Virginia, United States

Outcomes

Primary Outcomes

assess the safety of 3 dose levels

Time frame: one year

Secondary Outcomes

determine the immunogenicity of the 3 dose levels

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.