Status:
COMPLETED
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Healthy
Eligibility:
All Genders
18-31 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- healthy volunteers aged 18-31, m or f
Exclusion
- immunodeficiency
- pregnant
- chronic disease
- parental IgG
- abnormal labs
- drug use
- hiv
- hep c
- hep b
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00812071
Start Date
March 1 2008
End Date
May 1 2012
Last Update
August 20 2013
Active Locations (1)
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1
Hampton Roads Center For Clinical Research
Chesapeake, Virginia, United States, 23320