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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
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.
Imperial Clinical Research Facility, Imperial College London
London, United Kingdom
Number of PCR-confirmed Influenza Infections
Nasal wash viral load by quantitative polymerase chain reaction (qPCR)
Time frame: Baseline to day 28
Time to Algorithmic Detection of Heart Rate Abnormalities
Sensor data read-outs
Time frame: Baseline to day 10
Tissue Oxygen Levels
Sensor data read-outs
Time frame: Baseline to day 10
Participant-reported Total Symptom Score
Cumulative daily symptom score derived from self-reported upper and lower respiratory and systemic symptoms by diary card using the modified Jackson's symptom scoring system. Eight symptoms were scored: nasal obstruction, nasal discharge, sore throat, sneezing, cough, malaise, headache, and chills. Each symptom was scored 0-3, where 0=absent, 1=mild, 2=moderate and 3=severe. The maximum daily score is 24 and minimum daily score is 0.
Time frame: Day 1, Day 3 and Day 10
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