Influenza, Human Clinical Trial
Official title:
Evaluating Modes of Influenza Transmission Using a Human Challenge Model
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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