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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does RiVax induce to neutralize ricin toxin in humans?
How does RiVax compare to other ricin vaccines in terms of immunogenicity and safety profiles?
What biomarkers correlate with optimal immune response in NCT00812071 ricin vaccine trial?
Are there documented adverse events associated with alum-adjuvanted RiVax in phase 1 trials?
What are the current developments in ricin toxin countermeasures since the 2012 NCT00812071 trial?
Trial Locations
- Locations (1)
Hampton Roads Center For Clinical Research
🇺🇸Chesapeake, Virginia, United States
Hampton Roads Center For Clinical Research🇺🇸Chesapeake, Virginia, United States