Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults (NCT00094718) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults
United States56 participantsStarted 2005-02
Plain-language summary
West Nile (WN) virus infection is an emerging disease; WN infection may lead to paralysis, coma, and death. The purpose of this study is to test the safety of and immune response to a WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed against dengue virus.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Willing to be followed for the duration of the study
* Willing to use acceptable methods of contraception
* Good general health
Exclusion Criteria:
* Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
* Hematologic disease
* History of migraine headaches
* History of encephalitis
* Alcohol or drug abuse within 12 months prior to study entry
* History of severe allergic reaction or anaphylaxis
* Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
* HIV-1 infected
* Hepatitis C virus infected
* Hepatitis B surface antigen positive
* Known immunodeficiency syndrome
* Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
* Live vaccine within 4 weeks prior to study entry
* Killed vaccine within 2 weeks prior to study entry
* Blood products within 6 months prior to study entry
* Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while participating in this study
* Previously received a licensed or experimental yellow fever, tick-borne encephalitis, or dengue vaccine
* Surgical removal of spleen
* History of West Nile encephalitis
* His…
What they're measuring
1
Frequency of vaccine-related adverse effects, graded by severity, for each dose
Timeframe: Throughout study
2
Immunogenicity of vaccine against WN virus
Timeframe: Throughout study
Trial details
NCT IDNCT00094718
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)