Status:
COMPLETED
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
West Nile Fever Encephalitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 he...
Detailed Description
WN is widely distributed in Africa and Europe, where it is usually associated with mild illness. In the United States, WN is considered a public health threat because severe illness caused by WN infec...
Eligibility Criteria
Inclusion
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00094718
Start Date
February 1 2005
End Date
April 1 2005
Last Update
January 3 2013
Active Locations (2)
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1
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
2
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232