Safety and Immunogenicity Study of Rift Valley Fever Vaccine (NCT00584194) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
United States278 participantsStarted 2004-06
Plain-language summary
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Safety: All Incidences of Erythema
Timeframe: 12 months
Trial details
NCT IDNCT00584194
SponsorU.S. Army Medical Research and Development Command