NCT01710111

Evaluating Modes of Influenza Transmission

Evaluating Modes of Influenza Transmission Using a Human Challenge Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The ways in which influenza is transmitted between people are uncertain; for example, we do not know if large droplets or fine particles (aerosols) matter most; both are produced by coughing and sneezing. This means we cannot say what precautions work best in real life. Improving our understanding is vital to allow the development of guidelines and policies to help reduce the transmission of both pandemic and seasonal flu. The aim of this study is to explore how influenza is spread, specifically by looking at the importance of spread via small particles (aerosols/droplet nuclei) that are carried in respiratory sprays e.g. produced by coughing and sneezing. The primary objective of this study is: To estimate the contribution of aerosols/droplet nuclei to influenza transmission by determining the secondary attack rate (SAR) of influenza in Recipients randomised to a control arm (no intervention - allowing all modes of transmission) compared to Recipients randomised to an intervention arm (face shield and hand hygiene - allowing only transmission by aerosols/droplet nuclei) when both groups of Recipients are exposed to Donor volunteers infected with influenza via intranasal drops. The hypothesis is that: The SAR will be lower in Recipients exposed only to aerosols/droplet nuclei (intervention arm) compared to those exposed to all modes of transmission (the control arm): aerosols/droplet nuclei, droplet spray (larger respiratory droplets) and transmission through contact.

Detailed description

The study will take place in a quarantine facility. Some volunteers (Donors) will be infected with the influenza virus via droplets into the nose. Other volunteers (Recipients) will then be exposed to them by occupying the same room (in the day time) and taking part in certain activities e.g. playing card games. Some of the Recipients will wear face shields and clean their hands regularly during the times they are with the Donors. The wearing of face shields together with good hand hygiene should reduce the spread of infection through large respiratory droplets and contact with contaminated surfaces but will not prevent infection that occurs through aerosols in the air. Use of symptom diaries and diagnostic tests for influenza will allow the presence of subsequent illness to be identified. Volunteers will be required to participate in the quarantine facility for up to approximately 13 days (typically 9 for Donors and 13 days for Recipients), plus study screening clinics and followup. Additionally, during the study, environmental sampling will be performed looking for the presence of influenza virus. Air sampling and swabbing of surfaces and objects may provide information enabling us to better understand the routes of transmission.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DEVICE	Intervention Recipients Face Shield	Face shield and repeat hand hygiene measures

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-10-18
• Last updated: 2014-01-15

Locations

1 site across 1 country: United Kingdom