Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00812071
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
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.
- Detailed Description
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method assess the safety of 3 dose levels one year
- Secondary Outcome Measures
Name Time Method determine the immunogenicity of the 3 dose levels one year
Trial Locations
- Locations (1)
Hampton Roads Center For Clinical Research
🇺🇸Chesapeake, Virginia, United States