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 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 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:

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)
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

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 ( U.S. FDA Grant/Contract )
Study First Received:	December 15, 2008
Last Updated:	August 19, 2013

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


volunteers

ClinicalTrials.gov processed this record on July 21, 2017

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