Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

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

Study Objectives:

1. Continue to collect safety data on Live NDBR 101, Lot 4 Tularemia Vaccine (primary and booster doses), and
2. Continue to collect immunogenicity data on Live NDBR 101, Lot 4 Tularemia Vaccine, and
3. Provide potential protection for personnel at risk for occupational exposure to F. tularensis and collect data on incidence of occupational tularemia infection (subclinical and clinical) in immunized personnel.

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.