NCT00812071CompletedPhase 1
Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults
University of Texas Southwestern Medical Center1 site in 1 country30 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- assess the safety of 3 dose levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 31 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy volunteers aged 18-31, m or f
Exclusion Criteria
- •immunodeficiency
- •chronic disease
- •parental IgG
- •abnormal labs
Outcomes
Primary Outcomes
assess the safety of 3 dose levels
Time Frame: one year
Secondary Outcomes
- determine the immunogenicity of the 3 dose levels(one year)
Investigators
Ellen Vitetta
Director
University of Texas Southwestern Medical Center
Study Sites (1)
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