West Nile Fever Encephalitis Clinical Trial
Official title:
Phase 1 Study of the Safety and Immunogenicity of West Nile/Dengue-4 3'delta30 Chimeric Virus Vaccine (WN/DEN4-3'delta30), a Live Attenuated Vaccine for West Nile Encephalitis
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.
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 infection has caused paralysis, coma, and death, especially in the
elderly. This study will evaluate the safety and immunogenicity of a live attenuated
chimeric virus, WN/DEN4-3'delta30, which is derived from the DEN4 dengue virus and wild-type
WN serotypes.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
the lowest dose of WN/DEN4-3'delta30 or placebo at study entry. Cohort 2 will begin only
after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a
higher dose of WN/DEN4-3'delta30 or placebo. Cohort 3 will begin only after safety review of
all participants in Cohort 2. Participants in Cohort 3 will receive the highest dose of
WN/DEN4-3'delta30 or placebo. Immediately after receiving their injections, participants
will be observed for 30 minutes for immediate adverse reactions.
After vaccination, participants will be asked to monitor their temperatures every day for 16
days and on Day 19. Study visits will occur every other day after vaccination until Day 16,
followed by 5 additional visits at selected days through Day 180. Blood collection and a
targeted physical exam will occur at each study visit. Some participants will be asked to
undergo a skin biopsy or additional blood collection at selected visits.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04371003 -
Prospective Investigation of Oxidative Stress in West Nile Virus Infection
|