Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Completed · Phase 2

Conditions studied: Rift Valley Fever

In brief

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

Key facts

Study ID

NCT00584194

Run by

U.S. Army Medical Research and Development Command

People needed

278

Starts

2004-06-01

Expected to finish

2010-05-01

Last updated by the study team

2020-01-03

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U.S. Army Medical Research Institute of Infectious Diseases — Fort Deterick, Maryland, United States

Full record on ClinicalTrials.gov

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