Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118924
Status:
COMPLETED
Last Update Posted:
2008-01-21
First Post:
2005-07-08
Brief Title:
Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine LGTTP21DEN4 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 Tick-Borne LangatDengue 4 Chimera LGTTP21DEN4 a Live Attenuated Vaccine for Tick-Borne Encephalitis
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:
Tick-borne encephalitis TBE is a viral illness common in the Northern Hemisphere especially Europe and Asia TBE infection may lead to central nervous system problems and death The purpose of this study is to test the safety of and immune response to a TBE vaccine in healthy adults The vaccine is related to a live attenuated virus developed against dengue virus infection
Detailed Description:
TBE is a common illness in Europe and Asia where it is usually associated with mild illness but sometimes leads to long-term symptoms and even death This study will evaluate the safety and immunogenicity of a live attenuated chimeric virus LGTTP21DEN4 which is derived from the Langat flavivirus and DEN4 dengue virus serotypes
Each volunteer will be involved in the study for 180 days Participants in Cohort 1 will be randomly assigned to receive LGTTP21DEN4 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 LGTTP21DEN4 or placebo
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
Each volunteer will be involved in the study for 180 days Participants in Cohort 1 will be randomly assigned to receive LGTTP21DEN4 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 LGTTP21DEN4 or placebo
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 |
|---|---|---|---|
| H22030926B2 | None | None | None |