Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Study Objectives:

The objectives of this two-part, primary immunization and booster dose, study are to
continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD
200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine,
Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is
indicated; and, to provide potential protection for personnel at risk for occupational
exposure to the RVF virus and collect data on incidence of occupational RVF infection
(subclinical and clinical) in immunized personnel.

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 to be vaccinated at USAMRIID or be
otherwise authorized (with documentation) by the DOD

- 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 (Volunteer
Agreement Explanation and Affidavit).

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.