Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: West Nile Fever

In brief

West Nile (WN) virus infection is an emerging disease. Infection with WN virus may lead to paralysis, coma, and death. The purpose of this study is to determine the safety of and immune response to a two-dose regimen of a WN vaccine in healthy adults. The vaccine is based on a live attenuated vaccine developed against dengue virus.

Key facts

Study ID

NCT00537147

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

26

Starts

2008-03-01

Expected to finish

2009-06-01

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…

• Good general health
• Available for the duration of the trial
• Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if…

• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney 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
• Neutropenia (abnormally low neutrophil count)
• Alcohol or drug abuse within 12 months prior to study entry
• Elevated levels of alanine aminotransferase (ALT) and serum creatinine
• History of severe allergic reaction or anaphylaxis
• Severe asthma
• 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
• Surgical removal of spleen
• Blood products within 6 months prior to study entry
• History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
• Previously received a licensed or experimental yellow fever or dengue vaccine
• Investigational agent within 30 days of study entry
• 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

• Center for Immunization Research, Johns Hopkins School of Public Health (DC Location) — Washington D.C., District of Columbia, United States
• Center for Immunization Research, Johns Hopkins School of Public Health (MD Location) — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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