CompletedPhase 2

Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine

United States20 participantsStarted 2006-08

Plain-language summary

This study is to determine if a vaccine for Rift Valley Fever (RVF) is safe to give to humans. The study will examine how well the vaccine (RVF MP-12) stimulates the body's immune response (which fights off infection) and if the vaccine is stable or if the virus used to make the vaccine changes into a different form once injected into the body. Twenty healthy volunteers (18-50 years old) will be vaccinated with a single dose of undiluted RVF MP-12, injected into a muscle.

Who can participate

Age range

18 Years – 50 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: * Between 18 and 50 years old * Free of chronic medical conditions requiring ongoing therapy and in general good health as determined by a physician investigator * Have a current (within 30 days of scheduled blood donation for this study) complete blood (cell) count (CBC) to include a Hct and Hgb that show no evidence of anemia, and total white blood cell with differential platelet counts that are within normal range, as well as hepatic enzyme (AST, ALT, LDH) values that are within normal laboratory ranges * Negative human immunodeficiency virus (HIV) antibody test within 3 months preceding vaccination * No evidence of pre-existing liver disease or current infection with Hepatitis A, B, or C virus as determined by serology * No evidence for pre-existing eye disease, as determined by fundoscopic/slit lamp examination by the study ophthalmologist other than refractory changes * No evidence by history or serologic testing for previous infection with RVF virus or RVF vaccine * Subjects must agree to refrain from intimate contact (sexual activity), or use barrier contraception (e.g., condoms), for the 2-week period following vaccination * Females of child-bearing potential must have a negative serum pregnancy test on screening and the morning of vaccination prior to receipt of the vaccine and must agree to use a highly effective method of birth control during the first 3 months following receipt of the MP-12 vaccine. A highly effective method of birth control …

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

Safety as Measured by the Number of Adverse Events

Timeframe: up to 1 year

Trial details

NCT IDNCT00415051

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2016-12-06

View on ClinicalTrials.gov More Rift Valley Fever trials