Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: West Nile Fever Encephalitis
In brief
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.
Key facts
- Study ID
- NCT00094718
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 56
- Starts
- 2005-02-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2013-01-03
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
You may not qualify if…
- 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
- History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Pregnancy or breastfeeding
Where it is running
- Johns Hopkins School of Public Health — Baltimore, Maryland, United States
- Vanderbilt University School of Medicine — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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