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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

December 15, 2008
August 19, 2013
March 2008
January 2012   (final data collection date for primary outcome measure)
assess the safety of 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00812071 on ClinicalTrials.gov Archive Site
determine the immunogenicity of the 3 dose levels [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
Biological: RiVax
vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 31 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812071
3369-01, 1R01FD-03369--01-A1
Yes
Ellen Vitetta, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Lubin, Dr. Lubin Clinic
University of Texas Southwestern Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP