This study is designed to determine the safety and immunogenicity of a Rift Valley Fever
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.
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.
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.