Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05268302
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2022-02-09
Brief Title:
Dengue 4 Human Infection Model Dengue CVD 11000 DHIM-4
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase One Open Label Assessment of a Dengue-4-Virus-Live Virus Human Challenge - DENV-4-LVHC Virus Strain in Healthy US Adults
Status:
COMPLETED
Status Verified Date:
2024-03
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:
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood called viremia When volunteers are exposed to dengue on purpose it is called a challenge or Dengue Human Infection Model DHIM The research team is collecting information about the safety of the challenge and the best dose to use The information may help us to make a dengue challenge a DHIM that will test vaccines to protect people from dengue
Detailed Description:
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood called viremia When volunteers are exposed to dengue on purpose it is called a challenge or Dengue Human Infection Model DHIM The research team is collecting information about the safety of the challenge and the best dose to use The information may help the research team to make a dengue challenge a DHIM that will test vaccines to protect people from dengue The duration of participation will last for 180 days six months after challenge including up to 22 visits After participants are exposed to the weakened dengue virus the research team will follow them closely to measure their symptoms Like the flu participants might expect to have a headache rash body aches fever and chills or they may experience no symptoms whatsoever If participants do develop symptoms the research team will monitor them closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None