NCT03207152

Biomarkers Predicting Infectivity in an Experimental Human Influenza Model

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to test the hypothesis that gene transcriptional changes occur within 24 hours of virus exposure in the blood and nasal mucosa, and to identify early biomarker signatures that are predictive of higher viral shedding at the peak of disease

Detailed description

This study will systematically investigate the early pre-symptomatic period following exposure to influenza in humans. The data obtained will be essential for further understanding of the natural history of human antiviral responses, and will allow us to identify a panel of biomarkers that can predict which individuals will go on to more severe symptoms and higher viral shedding, so that treatments and other interventions can be made at an early stage.

Conditions

• Influenza A

Interventions

Type	Name	Description
BIOLOGICAL	Influenza A/California/04/09	Good Manufacturing Practices-certified Influenza A/California/04/09 3.5x10(4) TCID50 in 1 mL in DPBS delivered by intranasal drops

Timeline

• Start date: 2017-09-11
• Primary completion: 2018-05-08
• Completion: 2019-02-28
• First posted: 2017-07-02
• Last updated: 2018-07-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study