At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase One, Open Label, Assessment of a Dengue-4-Virus-Live Virus Human Challenge - (DENV-4-LVHC) Virus Strain in Healthy U.S. Adults
In Brief
A Phase 1 clinical trial evaluating Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose and Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge for Dengue. Completed, enrolled 20 participants across 1 site.
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 us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.
Study Details
Timeline
Interventions
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0.
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.