NCT02746211

Influenza Challenge Study in Healthy Volunteers

An Open Label Dose-Ranging Influenza Challenge Study in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.

Detailed description

The primary aim was to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection. In addition, the safety of the inoculum, the virus shedding from the nasal mucosa following challenge with Influenza., changes in mRNA and protein expression from blood and nasal brush samples. were assessed Self reported symptoms following challenge were recorded. Samples were taken to facilitate validation of CMI and other immunologically relevant assays in development Overall Trial Design: For each group of subjects, quarantine, challenge phase, release from quarantine and decontamination occured concurrently at the designated study site throughout the challenge phase of the study. The volunteers were be stratified into four groups depending on their intended challenge titre of virus: High titre Medium-high titre Medium-low titre Low titre Influenza inoculation (nasal drops)

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	High Titre Influenza virus	High Titre Influenza virus
BIOLOGICAL	Medium - High Influenza virus	Medium - High Influenza virus
BIOLOGICAL	Medium Low Titre Influenza virus	Medium Low Titre Influenza virus
BIOLOGICAL	Low titre	Low titre

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2016-04-21
• Last updated: 2016-04-21

Locations

1 site across 1 country: United Kingdom