Evaluating Modes of Influenza Transmission Between Humans

Summary

Most countries of the world, including the USA are making preparations for a possible influenza pandemic. Such an event will constitute a global public health emergency, but it is impossible to predict when this will happen. Up to 80 million people could die worldwide, so as much as possible needs to be done in advance to find ways of how the impact can be reduced. Although the investigators know that medical interventions such as anti-influenza drugs and antibiotics will be important, even in well resourced countries these might be in short supply. Vaccines will also be important but these will not be available until at least 4-5 months after the pandemic has started. This means that other non-pharmaceutical measures could well be important such as social distancing, school closures and the use of face masks. Guidance also needs to be developed so that families can care for each other whilst minimizing the spread of infection. To do these things, the investigators need to know how influenza is transmitted from person-to person. This is poorly understood at present. The investigators also need to know if face masks work before recommendations for public use can be made. The best way to study influenza transmission and the effectiveness of masks is to perform a study using healthy adult volunteers. The investigators will do this by giving some volunteers normal influenza via nasal drops. When they get symptoms the investigators will create an 'experimental household' by getting them to live with other non-infected volunteers for 48 hours, in a specially designed quarantine isolation unit. Some of the non-infected volunteers will be unprotected; others will be selected randomly to wear either face masks or a special plastic 'cloak' so that they do not touch their faces; another group will wear both. The investigators will then measure the rate at which the different groups get 'flu'. From these data the investigators can work out whether it is touching the face or coughing and sneezing that spreads flu most or whether both are important; the investigators can also deduce how well face masks work to prevent spread. The investigators need almost 2000 volunteers for this study, it will take at least 2 years to complete and it will be very costly, however, the results will be of global importance. If the study is successful, the investigators can tell governments around the world whether face masks work to prevent influenza and be clearer about the guidance that should be given to families.

Conditions

• Influenza

Interventions

BEHAVIORAL

No face touch

DEVICE

Surgical face mask

DEVICE

Surgical face mask + no face touch

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• University College, London

  collaborator OTHER

• Retroscreen Virology Ltd.

  collaborator INDUSTRY

• University of Nottingham

  lead OTHER

Principal Investigators

• JONATHAN VAN-TAM, MD · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2010-04-30

Completion

2010-06-30

Countries

• United Kingdom

Study Locations