Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine
Condition: Tularemia
MeSH terms: Tularemia
Intervention: Live F tularensis Vaccine
Intervention description: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 484.0
Sex: All
Minimum age: 17 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Live Vaccine Strain (LVS), Bacterial Infections, Ulceroglandular, Oculoglandular

Summary:

      This study is designed to determine the safety and immunogenicity of a Live Francisella
      tularensis Vaccine
    

Eligibility criteria:

        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. Volunteers must agree not to become pregnant
             for 3 months after receipt of the vaccine.>

          -  Subject must be actively enrolled in the SIP >

          -  Subjects must be considered 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. Examinations or tests may be repeated within 1 year
             at the discretion of the enrolling physician.>

          -  Volunteer must be willing to return for all follow-up visits on days 1, 2, 7, once
             between days 12-16, and once between days 28-35, days 56-84 (if needed), all visits
             for serology, as well as an annual visit while enrolled in protocol.>

          -  Volunteer 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
             volunteer's participation in the study. >

        Exclusion Criteria:>

          -  Clinically significant abnormal lab results 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.>

          -  Any other medical condition at the discretion of the PI.>

          -  Antibiotic therapy for 7 days before vaccination.>

          -  Females must not be pregnant or lactating (females must agree to not become pregnant
             for 3 months after vaccination).>

          -  Any known allergies to excipients 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. >