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Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

Primary Purpose

Influenza A H3N2

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Lumee Oxygen Platform

About this trial

This is an interventional basic science trial for Influenza A H3N2 focused on measuring Influenza A H3N2

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy persons aged 18 to 55 years, able to give informed consent

Exclusion Criteria:

Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
Inhaled bronchodilator or steroid use within the last 12 months
Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 3 months
Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
Smoking in the past 6 months OR >5 pack-year lifetime history
Subjects with allergic symptoms present at baseline
Clinically relevant abnormality on chest X-ray
Any ECG abnormality deemed clinically significant.
Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease
Subjects with known or suspected immune deficiency
Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome
History of frequent nose bleeds
Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
Pregnant or breastfeeding women
Positive urine drug screen
Detectable baseline antibody titres against influenza challenge strains
History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations.
Participants may only recruited if they have previously been involved in research if they have completed the earlier study and are beyond the washout period of any administered drugs or period of effect of any intervention that would cause interference for either study.

Sites / Locations

Imperial Clinical Research Facility, Imperial College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Influenza A

Arm Description

Participants will be inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x105 TCID50 in a volume of 0,5mL via intranasal drops or spray. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they will be followed up for up to 6 months post-inoculation.

Outcomes

Primary Outcome Measures

Number of PCR-confirmed Influenza Infections

Nasal wash viral load by quantitative polymerase chain reaction (qPCR)

Secondary Outcome Measures

Time to Algorithmic Detection of Heart Rate Abnormalities

Sensor data read-outs

Tissue Oxygen Levels

Sensor data read-outs

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.

Full Information

NCT ID

NCT04204993

First Posted

November 12, 2019

Last Updated

August 17, 2023

Sponsor

Imperial College London

Collaborators

Duke University, RTI International, Defense Advanced Research Projects Agency

1. Study Identification

Unique Protocol Identification Number

NCT04204993

Brief Title

Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

Official Title

Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 11, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

May 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

Collaborators

Duke University, RTI International, Defense Advanced Research Projects Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A H3N2

Keywords

Influenza A H3N2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Influenza A

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Lumee Oxygen Platform

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of PCR-confirmed Influenza Infections

Description

Nasal wash viral load by quantitative polymerase chain reaction (qPCR)

Time Frame

Baseline to day 28

Secondary Outcome Measure Information:

Title

Time to Algorithmic Detection of Heart Rate Abnormalities

Description

Sensor data read-outs

Time Frame

Baseline to day 10

Title

Tissue Oxygen Levels

Description

Sensor data read-outs

Time Frame

Baseline to day 10

Title

Participant-reported Total Symptom Score

Description

Time Frame

Day 1, Day 3 and Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy persons aged 18 to 55 years, able to give informed consent Exclusion Criteria: Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood Inhaled bronchodilator or steroid use within the last 12 months Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 3 months Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks Smoking in the past 6 months OR >5 pack-year lifetime history Subjects with allergic symptoms present at baseline Clinically relevant abnormality on chest X-ray Any ECG abnormality deemed clinically significant. Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease Subjects with known or suspected immune deficiency Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome History of frequent nose bleeds Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study Pregnant or breastfeeding women Positive urine drug screen Detectable baseline antibody titres against influenza challenge strains History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations. Participants may only recruited if they have previously been involved in research if they have completed the earlier study and are beyond the washout period of any administered drugs or period of effect of any intervention that would cause interference for either study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Chiu

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imperial Clinical Research Facility, Imperial College London

City

London

ZIP/Postal Code

W2 1PG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared with Duke university, and RTI International, such as ethnicity and age. It will be identifiable only by their unique study code, with no personal details.

IPD Sharing Access Criteria

According to study protocol

Citations:

PubMed Identifier

35759279

Citation

Temple DS, Hegarty-Craver M, Furberg RD, Preble EA, Bergstrom E, Gardener Z, Dayananda P, Taylor L, Lemm NM, Papargyris L, McClain MT, Nicholson BP, Bowie A, Miggs M, Petzold E, Woods CW, Chiu C, Gilchrist KH. Wearable Sensor-Based Detection of Influenza in Presymptomatic and Asymptomatic Individuals. J Infect Dis. 2023 Apr 12;227(7):864-872. doi: 10.1093/infdis/jiac262.

Results Reference

derived

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Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

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