Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786457
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2020-11-24
Brief Title:
ADVP005 Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge DENV-1-LVHC
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 1 Open-Label Clinical Trial With Dengue-1-Virus Live Virus Human Challenge DENV-1-LVHC Assessment of Healthy US Adults Previously Primed With Tetravalent Dengue Virus Purified Inactivated Vaccine TDEN-PIV and Boosted With Tetravalent Dengue Virus Live Attenuated Vaccine Formulation TDEN LAV
Status:
COMPLETED
Status Verified Date:
2021-10
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 the protection of volunteers previously vaccinated with Tetravalent Dengue Virus TDEN Purified Inactivated Vaccine PIV with alum and boosted with TDEN live attenuated vaccine LAV formulation against a weakened form of an experimental dengue virus challenge The Investigators will also include people that have not received the study vaccine The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge
Detailed Description:
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus TDEN Purified Inactivated Vaccine PIV with alum and boosted with TDEN live attenuated vaccine LAV formulation against a weakened form of an experimental dengue virus challenge The Investigators will also include people that have not received the study vaccine The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge The information will help Investigators develop vaccines to protect people from dengue Participation is voluntary The duration of participation will last for 180 days six months After participants are exposed to the weakened dengue virus the Investigators 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 a participant does develops symptoms the Investigators will monitor himher closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur Participants will be compensated for their time
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