Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin (FDA-OPD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00812071 |
Recruitment Status :
Completed
First Posted : December 19, 2008
Last Update Posted : August 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Biological: RiVax | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | May 2012 |
- Biological: RiVax
vaccine
- assess the safety of 3 dose levels [ Time Frame: one year ]
- determine the immunogenicity of the 3 dose levels [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 31 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812071
United States, Virginia | |
Hampton Roads Center For Clinical Research | |
Chesapeake, Virginia, United States, 23320 |
Principal Investigator: | Lubin, Dr. | Lubin Clinic |
Responsible Party: | Ellen Vitetta, Director, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00812071 |
Other Study ID Numbers: |
3369-01 1R01FD003369-01A1 ( U.S. FDA Grant/Contract ) |
First Posted: | December 19, 2008 Key Record Dates |
Last Update Posted: | August 20, 2013 |
Last Verified: | August 2013 |
volunteers |