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

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ClinicalTrials.gov Identifier: NCT00812071
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Ellen Vitetta, University of Texas Southwestern Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: RiVax Phase 1

Detailed Description:
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Biological: RiVax
    vaccine

Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. assess the safety of 3 dose levels [ Time Frame: one year ]

Secondary Outcome Measures :
  1. determine the immunogenicity of the 3 dose levels [ Time Frame: one year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 19, 2008    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

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