Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089908
Status:
COMPLETED
Last Update Posted:
2008-01-18
First Post:
2004-08-17
Brief Title:
Safety of and Immune Response to a Dengue Virus Vaccine rDEN1delta30 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 I Study of the Safety and Immunogenicity of rDEN1delta30 a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Dengue fever which is caused by dengue viruses is a major health problem in tropical and subtropical regions of the world The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults
Detailed Description:
More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection Dengue viruses cause dengue fever as well as the more severe dengue hemorrhagic fevershock syndrome and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries This study will evaluate the safety and immunogenicity of a live attenuated dengue virus called rDEN1delta30 which is derived from the Western Pacific DEN1 serotype
This study will last 180 days Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 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 rDEN1delta30 or placebo
After vaccination participants will be asked to monitor their temperature every day for 16 days Study visits will occur every other day after vaccination until Day 16 followed by 4 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 rDEN1delta30 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 rDEN1delta30 or placebo
After vaccination participants will be asked to monitor their temperature every day for 16 days Study visits will occur every other day after vaccination until Day 16 followed by 4 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 |
|---|---|---|---|
| H22040423B2 | None | None | None |