Safety and Immunogenicity Study of Rift Valley Fever Vaccine (RVF)

Inclusion Criteria:

Parts A & B:

• At least 18 years old, or if active military duty, 17 years old,
• Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
• Subject must be actively enrolled in the SIP
• Subjects must be at risk for exposure to RVF virus,
• Subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in 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 have signed and dated the approved informed consent.

Additional Inclusion Criteria for Part B:

• Completion of primary series and any follow-up titer (PRNT80) < 1:40 from the current or a previous RVF IND 365 protocol.

Exclusion Criteria

Parts A & B:

• Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
• Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
• Confirmed HIV infection.
• Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
• Any serious or life-threatening allergies to any component of the vaccine: formalin,human serum albumin,neomycin,streptomycin
• Administration of any other vaccine within 28 days of any dose of RVF vaccine.
• Any unresolved adverse event resulting from a previous immunization.

Additional Exclusion Criteria for Part B:

• An adequate PRNT80 (≥ 1:40) after completion of primary series.