NCT05268302

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose	Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0.
BIOLOGICAL	Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge	Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 366 in previously dosed participants.

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-01-04
• Completion: 2024-01-04
• First posted: 2022-03-07
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study