Status:
UNKNOWN
Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Tularemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine
Detailed Description
Study Objectives: 1. To assess the safety of live F. tularensis vaccine NDBR 101. 2. To assess the immunogenicity of live F. tularensis vaccine NDBR 101.
Eligibility Criteria
Inclusion
- At least 18 years old.
- Females of childbearing potential must agree to have a urine or serum pregnancy test on vaccination day, 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.
- Subjects must be at risk for exposure to F. tularensis.
- Subjects must have an up-to-date (within 1 year) medical history including concomitant medications, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator.
- Subject must be willing to return for all follow-up visits on days 1 and 2, between days 5-9, 12-16, 28-35, and 56-84 (if needed), all visits for serology, and the closeout interview 6 months (±14 days) after vaccination or revaccination.
- 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.
Exclusion
- Over the age of 65 Years.
- Vaccinated against tularemia within the last 10 years or had a documented, confirmed tularemia infection.
- Clinically significant abnormal lab results including evidence of hepatitis C, hepatitis B carrier state, or elevated liver function tests (two times the normal range or at the discretion of the 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. Subjects must agree not to become pregnant for 3 months after receipt of the vaccine.
- Any known allergies to any component of the vaccine:
- Modified casein partial hydrolysate medium Glucose cysteine hemin agar Sucrose gelatin agar stabilizer
- Administration of another vaccine within 4 weeks of tularemia vaccination.
- Any unresolved AE resulting from a previous immunization.
Key Trial Info
Start Date :
August 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00787826
Start Date
August 28 2009
End Date
December 1 2021
Last Update
April 29 2021
Active Locations (1)
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1
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States, 21702