NCT04298138

Dengue 3 Human Infection Model (DENV-3)

Phase One, Open Label Assessment of a Dengue-3-Virus-Live Virus Human Challenge - (DENV-3-LVHC) Virus Strain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. This study will examine the safety and effectiveness of the Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Detailed description

Healthy subjects between 18 and 45 years old will be inoculated with Dengue 3 Live Virus Human Challenge (DENV-3-LVHC) in a dose ranging study. Subjects will be closely monitored for the first 28 days with continued follow up through 6 months. Clinical and laboratory parameters, viremia and antibody levels will be assessed. The goal is to determine the dose that produces uncomplicated dengue-like illness.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)	Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 administered as a single injection.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2020-03-06
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study