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Sponsored by: |
U.S. Army Medical Research and Materiel Command |
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Information provided by: | U.S. Army Medical Research and Materiel Command |
ClinicalTrials.gov Identifier: | NCT00787826 |
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Condition | Intervention | Phase |
---|---|---|
Tularemia |
Biological: Live Francisella Tularensis Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Site Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4 in Healthy Adults At-Risk for Exposure to Francisella Tularensis |
Estimated Enrollment: | 500 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Approximately 0.0025 mL of vaccine will be administered percutaneously with a bifurcated needle using 15 pricks on the volar surface of the forearm.
Vaccination may be repeated up to two times within the year if successful vaccination is not demonstrated by a positive "take" reaction and a MA titer of ≥ 1:20.
Study Objectives:
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At least 18 years old, or if on active military duty, 17 years old Females of childbearing potential must agree to have a urine pregnancy test immediately before vaccination (Exception: documented hysterectomy or > 3 years of menopause). The results must be negative. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
Subject must be actively enrolled in the SIP at USAMRIID to be vaccinated at USAMRIID.
Subjects must be at risk for exposure to F. tularensis. Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.
Exclusion Criteria:
Over 65 years of age. Individuals with MA titer ≥1:20 who have history of significant exposure (as determined by the PI) to F. tularensis (i.e., raised rabbits, hunted and skinned rabbits, etc.). Clinically significant abnormal lab results (within 60 days before vaccination) including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests (2X normal values) or at discretion of PI. Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
Confirmed HIV infection. A medical condition that, in the judgment of the Principal Investigator (PI), would impact subject safety.
Antibiotic therapy within 7 days before vaccination. Pregnancy or lactation. Any known allergies to any components of the vaccine. Administration of another live vaccine within 4 weeks or an inactivated vaccine (generally) within 7 days of tularemia vaccination.
Any unresolved adverse event resulting from a previous immunization. Subject must agree to report any adverse event which may or may not be associated with administration of the test article for at least 28 days after vaccination. All serious and unexpected adverse events will be reported for the duration of the subject's participation in the study.
Subject must be willing to return for all follow-up visits on days 1 and 2 and between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the close-out interview 4 months (±14 days) after vaccination or revaccination.
Contact: Robert Rivard, MD | 301-619-4646 | robert.rivard@amedd.army.mil |
Contact: Diane Ullman, MS | 301-619-4828 | diane.ullman@amedd.army.mil |
United States, Maryland | |
U.S. Army Medical Research Institute of Infectious Diseases | |
Fort Detrick, Maryland, United States, 21702 |
Principal Investigator: | Robert Rivard, MD | USAMRIID Medical Division |
Responsible Party: | USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance ) |
Study ID Numbers: | A-15207.a, FY 07-15 |
Study First Received: | November 5, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00787826 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Live Vaccine Strain (LVS), Bacterial Infections, Ulceroglandular, Oculoglandular |
Bacterial Infections Tularemia Healthy Tick-Borne Diseases Gram-Negative Bacterial Infections |
Bacterial Infections Tularemia Tick-Borne Diseases Gram-Negative Bacterial Infections |