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Trial record 1 of 1 for:    rivax
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Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin (FDA-OPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812071
First Posted: December 19, 2008
Last Update Posted: August 20, 2013
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.
Information provided by (Responsible Party):
Ellen Vitetta, University of Texas Southwestern Medical Center
  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:
    Biological: RiVax
    vaccine
Detailed Description:
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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 )
First Submitted: December 15, 2008
First Posted: December 19, 2008
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Ellen Vitetta, University of Texas Southwestern Medical Center:
volunteers