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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • assess the safety of 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • determine the immunogenicity of the 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years to 31 Years   (Adult)
Genders Eligible for Study:   Both
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

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 
Study First Received: December 15, 2008
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
volunteers

ClinicalTrials.gov processed this record on September 29, 2016