Clinical Trial: Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4)

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Phase One, Open Label, Assessment of a Dengue-4-Virus-Live Virus Human Challenge - (DENV-4-LVHC) Virus Strain in Healthy U.S. Adults

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 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 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.
Sponsor: University of Maryland, Baltimore

Current Primary Outcome: solicited injection site adverse events until 7 days post virus inoculation

Original Primary Outcome: solicited injection site adverse events until 7 days post virus inoculation

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Maryland, Baltimore

Dates:
Date Received: February 09, 2022
Date Started: February 28, 2022
Date Completion: January 01, 2024
Last Updated: March 07, 2023
Last Verified: March 01, 2023