Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults (NCT00537147) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4delta30) in Healthy Adults
United States26 participantsStarted 2008-03
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Good general health
* Available for the duration of the trial
* Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria:
* 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 investi…
What they're measuring
1
Frequency of vaccine-related adverse events, as classified by both intensity and severity through active and passive surveillance
Timeframe: Throughout study
2
Immunogenicity, determined by anti-WN/DEN4 neutralizing antibody titer
Timeframe: At study entry, Days 28 and 42 after first vaccination, and Days 180, 208, and 222 after second vaccination
Trial details
NCT IDNCT00537147
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)