Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine (NCT00415051) | Clinical Trial Compass
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 range18 Years – 50 Years
SexALL
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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 …
What they're measuring
1
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