Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults
West Nile Fever Encephalitis
About this trial
This is an interventional prevention trial for West Nile Fever Encephalitis focused on measuring Chimeric Virus Vaccine, West Nile Virus, Dengue Virus
Eligibility Criteria
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 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
Sites / Locations
- Johns Hopkins School of Public Health
- Vanderbilt University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
1
2
3
4
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^4 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 1 are analyzed.
One subcutaneous vaccination with WN/DEN4-3'delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm. This arm may enroll after the results from Arm 2 are analyzed.
One subcutaneous vaccination with placebo vaccine into the deltoid region of either arm.