Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

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.