Expired Study
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Fort Detrick, Maryland 21702


Purpose:

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


Study summary:

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.


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.


NCT ID:

NCT00584194


Primary Contact:

Principal Investigator
Janice Rusnak, MD
USAMRIID Medical Division


Backup Contact:

N/A


Location Contact:

Fort Detrick, Maryland 21702
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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