Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094718
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2004-10-21
Brief Title:
Safety of and Immune Response to a West Nile Virus Vaccine WNDEN4-3delta30 in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase 1 Study of the Safety and Immunogenicity of West NileDengue-4 3delta30 Chimeric Virus Vaccine WNDEN4-3delta30 a Live Attenuated Vaccine for West Nile Encephalitis
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 healthy adults The vaccine is based on a live attenuated vaccine developed against dengue virus
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 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 WNDEN4-3delta30 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 WNDEN4-3delta30 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 WNDEN4-3delta30 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 WNDEN4-3delta30 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
This study will last 180 days Participants in Cohort 1 will be randomly assigned to receive the lowest dose of WNDEN4-3delta30 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 WNDEN4-3delta30 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 WNDEN4-3delta30 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H22041006A1 | None | None | None |