Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Safety: All Incidences of Erythema
Study Overview
Brief Summary
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
TSI-GSD 200 RVF Vaccine
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.
Intervention: TSI-GSD 200 RVF Vaccine (Biological)
Outcomes
Primary Outcomes
Safety: All Incidences of Erythema
Time Frame: 12 months
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Secondary Outcomes
- Immunogenicity: Geometric Mean Titers Before 6-month Booster(Before 6-month booster)
- Immunogenicity: Geometric Mean Titers After 6-month Booster(month 6 after dose 4)
- Immunogenicity: Geometric Mean Titers After 3rd Vaccination(28 days after dose 3)
- Immunogenicity: Geometric Mean Titers at 12 Months(at 12 months)