Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Condition: Rift Valley Fever
MeSH terms: Coccidioidomycosis; Coccidiosis; Rift Valley Fever; Fever
Intervention: TSI-GSD 200 RVF Vaccine
Intervention description: Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF

Summary:

      This study is designed to determine the safety and immunogenicity of a Rift Valley Fever
      (RVF) Vaccine
    

Eligibility criteria:

        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.