NCT03869060

Expansion of a Dengue-1 Live Virus Human Challenge

Phase One, Open Label Expansion of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-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 supports the expansion of the data set of the current Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) model to produce uncomplicated dengue-like illness.

Detailed description

This is an expansion of a previous study conducted under NCT02372175. In this study up to nine healthy subjects between 18 and 45 years old will be inoculated with Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at a dose used in the previous 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 assess. The goal is to expand the data set of symptoms produced by uncomplicated dengue-like illness.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)	Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5

Timeline

• Start date: 2019-03-11
• Primary completion: 2019-09-20
• Completion: 2019-09-20
• First posted: 2019-03-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study