Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
Condition: Influenza A H3N2
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      The aim of the study is to investigate disease in volunteers deliberately infected with
      influenza A(H3N2), including biological markers of inflammation and immune response, and
      changes in physiological parameters including heart rate, respiratory rate, physical
      activity, oxygen saturation and electrocardiographic data during the onset of influenza
      infection. Ultimately, this may lead to prediction of symptomatic disease at an earlier stage
      to allow more effective interventions. The experimental medicine study design will involve
      human influenza infection challenge, whereby volunteers will be inoculated with influenza
      virus and monitored in hospital for 10 days as they develop and get better from flu.
      Continuously-monitoring wearable physiological sensors will be given to the participants 7
      days before this and worn continuously until the end of the flu infection.
    

Detailed description: 
      Influenza ('flu') is one of the most common causes of severe lung infection. Seasonal flu
      affects between 10 and 46% of the population each year and causes around 12 deaths in every
      100,000 people infected. Furthermore, new strains of flu viruses emerge unpredictably every
      few years, causing pandemics that spread rapidly across the world. Since currently available
      antiviral drugs and vaccines cannot prevent these outbreaks, it is essential to be able to
      identify flu infections at an early stage to enable rapid treatment of individuals and
      implementation of public health measures.

      The aim of the study is to investigate disease in volunteers deliberately infected with
      influenza A(H3N2), including biological markers of inflammation and immune response, and
      changes in physiological parameters including heart rate, respiratory rate, physical
      activity, oxygen saturation and electrocardiographic data during the onset of influenza
      infection. To achieve this, the investigators will recruit healthy volunteers and inoculate
      them with a flu virus, after which they will be observed in hospital while they develop a
      cold. Each volunteer will be given a number of devices that they will wear before and during
      infection. In addition, they will have blood and nasal samples taken to examine the way their
      immune system responds to infection. The resulting data will be analysed to see if the
      sensors data correlate with the onset of infection and these will be compared with measures
      of the immune response. Ultimately, the investigators anticipate that optimised sensor data
      from devices to be developed may be useful in rapidly detecting when someone is about to
      develop flu infection, so that they can quickly be treated and outbreaks may be identified at
      an early stage.
    

Intervention name(s): Lumee Oxygen Platform
Intervention type(s): Device
Intervention description(s): Two sensors will be inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader is placed on top of the skin over the area where the sensor has been placed to measure local oxygen content.
Intervention model: Single Group Assignment
Intervention model description: Biological: Influenza A/Belgium/4217/2015 at a dose of 5x105 TCID50 in a volume of 0.5 milliliters via intranasal drops
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza A H3N2