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

This study is currently recruiting participants.
Verified August 2012 by FDA Office of Orphan Products Development
Sponsor:
Information provided by (Responsible Party):
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00812071
First received: December 15, 2008
Last updated: August 28, 2012
Last verified: August 2012
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 FDA Office of Orphan Products Development:

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 ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: RiVax
    vaccine
  Eligibility

Ages Eligible for Study:   18 Years to 31 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812071

Locations
United States, Virginia
Hampton Roads Center For Clinical Research Recruiting
Chesapeake, Virginia, United States, 23320
Contact: RIchard Craven, MD     949-218-9969        
Sponsors and Collaborators
FDA Office of Orphan Products Development
Investigators
Principal Investigator: Lubin, Dr. Lubin Clinic
  More Information

No publications provided

Responsible Party: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00812071     History of Changes
Other Study ID Numbers: 3369-01, 1R01FD-03369--01-A1
Study First Received: December 15, 2008
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
volunteers

ClinicalTrials.gov processed this record on May 19, 2013