Influenza Challenge Study in Healthy Volunteers

Influenza Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT02746211
• Study type: Interventional
• Source: Hvivo
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2008
• Completion date: December 2008