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Trial record 1 of 1 for:
rivax
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin (FDA-OPD)
This study has been completed.
Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Ellen Vitetta, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00812071
First received: December 15, 2008
Last updated: August 19, 2013
Last verified: August 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Biological: RiVax | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults |
Further study details as provided by Ellen Vitetta, University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- assess the safety of 3 dose levels [ Time Frame: one year ]
Secondary Outcome Measures:
- determine the immunogenicity of the 3 dose levels [ Time Frame: one year ]
| Enrollment: | 30 |
| Study Start Date: | March 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: RiVax
vaccine
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
Eligibility| Ages Eligible for Study: | 18 Years to 31 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812071
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812071
Locations
| United States, Virginia | |
| Hampton Roads Center For Clinical Research | |
| Chesapeake, Virginia, United States, 23320 | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
| Principal Investigator: | Lubin, Dr. | Lubin Clinic |
More Information
| Responsible Party: | Ellen Vitetta, Director, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00812071 History of Changes |
| Other Study ID Numbers: |
3369-01 1R01FD003369-01A1 ( U.S. FDA Grant/Contract ) |
| Study First Received: | December 15, 2008 |
| Last Updated: | August 19, 2013 |
Keywords provided by Ellen Vitetta, University of Texas Southwestern Medical Center:
|
volunteers |
ClinicalTrials.gov processed this record on September 21, 2017