Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated (NCT00869713) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
United States98 participantsStarted 2009-09
Plain-language summary
This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years old.
. Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.
. Females must not be breast-feeding.
. Subject must be at risk for exposure to RVF virus.
. Subject 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 to qualify for enrollment may be repeated at the discretion of the investigators.
. Subject must sign and date the approved informed consent document.
. For initiation of primary series, RVF PRNT80 \<1:10.
. For RE-ENTRY into this protocol or ROLLOVER from an earlier RVF protocol to receive a booster, RVF PRNT80 \<1:40 within past 1 year
Exclusion criteria
. Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PRNT80 ≥ 1:40 after primary series
Timeframe: Between Days 28-42
2
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
Timeframe: 7 months
3
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
Timeframe: up to 5 years
4
Median duration of PRNT80 ≥ 1:40 in initial responders
Timeframe: up to 5 years
5
Median duration of PRNT80 ≥ 1:40 in initial non-responders
Timeframe: up to 5 years
6
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
Timeframe: up to 1 year
Trial details
NCT IDNCT00869713
SponsorU.S. Army Medical Research and Development Command
. Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.
. Personal history of immunodeficiency or current treatment with immunosuppressive medication.
. Confirmed positive human immunodeficiency virus (HIV) titer.
. Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.
. Any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells RVF virus inactivated
. Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.
. Any unresolved adverse event resulting from a previous immunization.