Influenza, HumanEMITNCT01710111
Evaluating Modes of Influenza Transmission
A study testing Intervention Recipients Face Shield in people with Influenza, Human, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Intervention Recipients Face Shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Weight: A total body weight ≥50 kg and a Body mass index (BMI) >18 (if BMI is >32, a body fat percentage within WHO and NIH range for gender and age. BMI [kg/m2] = Body weight [kg] ÷ Height2 [m2]
- Contraception: Nonsterilised males must agree to refrain from fathering a child from the point of entering quarantine until the Day 28 follow up visit. Use of one effective form of contraception is acceptable. Sexually active females of childbearing potential must agree to use 2 effective methods of avoiding pregnancy that are deemed to be effective from the point of entry into the quarantine unit until the Day 28 follow up visit. Acceptable forms of effective contraception include:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject].
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- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
- Informed Consent: An informed consent document signed and dated by the subject and investigator
- Serosuitability: Serosuitable for challenge virus
Who cannot join
- Smoking: Significant history of any tobacco use at any time (≥ total 10 pack year history, eg. one pack a day for 10 yrs)
- Pregnancy/Lactation: Subjects who are pregnant or nursing, or who have a positive pregnancy test at any point in study
- Previous Medical History: Presence of significant acute or chronic, uncontrolled medical illness, that in the view of Investigator(s)is associated with increased risk of complications of respiratory viral illness
- Pulmonary Function: Abnormal pulmonary function in the opinion of the investigator evidenced by clinically significant abnormalities in spirometry
- Immune: History or evidence of autoimmune disease or known impaired immune responsiveness (of any cause)
- Asthma: History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology.History of childhood asthma until and including the age of 12 is acceptable.
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- HIV \& Hepatitis: Positive HIV, hepatitis B (HBV), or hepatitis C (HCV) antibody screen.
- Anatomic abnormalites of nasopharynx:Significant abnormality altering anatomy of nose or nasopharynx
- Epistaxis: Clinically significant history of epistaxis
- Nasal Surgery: Any nasal or sinus surgery within 6 months of inoculation
- Fainting: Recent (within the last 3 years of the screening visit) and/or recurrent history of clinically significant autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc)
- Lab Test/ECG: Laboratory test or ECG which is abnormal and deemed by investigator(s) to be clinically significant.
- Drugs of abuse etc: Confirmed Positive test for class A drugs or alcohol that cannot be satisfactorily explained
- Venous Access: Venous access deemed inadequate for phlebotomy (and IV infusion) demands of study
- Hayfever: Subjects symptomatic with hayfever on admission or prior to inoculation.
- Allergies: Any known allergies to excipients in challenge virus inoculum
- Healthcare workers: Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge. Healthcare workers should not work with patients until 14 days after challenge or until symptoms are fully resolved (whichever is longer). In particular, health care workers who work in units housing, elderly, disabled or severely immunocompromised patients (e.g. bone marrow transplant units) will be excluded.
- Household members: Presence of household member or close contact (for an additional 2 weeks after discharge from the isolation facility) who is:
- less than 3 years of age
- any person with any known immunodeficiency
- any person receiving immunosuppressant medications
- any person undergoing or soon to undergo cancer chemotherapy within 28 days of viral inoculation
- any person with diagnosed emphysema or chronic obstructive pulmonary disease (COPD), is elderly residing in a nursing home, or with severe lung disease or medical condition that may include but not exclusive to conditions listed (detailed in protocol); or
- any person who has received a transplant (bone marrow or solid organ)
- Travel: Intending to travel within next 3 months (to countries for which travel vaccinations are recommended).
- Employers: Those employed or immediate relatives of those employed at RVL or staff/ students working directly for any unit in which CI works.
- Blood loss/receipt: Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the 3 months prior to inoculations.
- Use of nasal congestion products - acute/chronic: Acute use i.e. within 7 days prior to viral challenge of any medication or other product (prescription or OTC), for symptoms of hayfever, rhinitis, nasal congestion or respiratory tract infection.
- Other IMP or virus challenges: Receipt of any investigational drug within 3 months prior inoculation. Receipt of more than 4 investigational drugs within the previous 12 months. Prior participation in a clinical trial with same strain of respiratory virus. Participation in other respiratory virus challenge within 1 year prior to challenge
- Chemotherapy: Receipt of systemic glucocorticoids, antiviral drugs, and immunoglobulin's (Igs) or other cytotoxic or immunosuppressive drug within 6 months prior to dosing. Receipt of any systemic chemotherapy agent at any time.
- Current or recent respiratory infection: Presence of significant respiratory symptoms on day of challenge or between admission for challenge and challenge with/exposure to virus. History suggestive of respiratory infection within 14 days prior to admission for challenge exposure.
- General screening: Any other finding in medical interview, physical exam, or screening investigations that, in the opinion of the investigator, GP or sponsor, deem subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Influenza, Human
- Being tested
- Intervention Recipients Face Shield
- Keywords
- Human challenge model, Quarantine study, Influenza virus, Modes of transmission, Droplet spray, Droplet nuclei, Secondary attack rate, Face shield, Hand hygiene, Fomites, Environmental deposition, Environmental dispersion
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Recipients Face ShieldDevice
Face shield and repeat hand hygiene measures
| Study group | Role | What they receive |
|---|---|---|
| Intervention Recipients Face Shield | Experimental | Face shield and repeat hand hygiene measures Receives: Device: Intervention Recipients Face Shield |
| Control Recipients | No intervention | No face shield and no repeat hand hygiene measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Secondary Attack Rate (SAR)
The primary endpoint is the difference in SAR of influenza in Recipients randomised to an intervention arm (face shield and hand hygiene -droplet nuclei transmission only) compared to Recipients randomised to a control arm (no intervention - all modes of transmission).
Measured: Day -2 to day 28(±3)
Secondary outcomes (4)
Viral parameters of infection and association with infection transmission.
To evaluate and compare the incidence, duration and quantity of human virus shedding.
To explore and compare the association of the incidence (infection rate as well as daily incidence), duration and quantity of virus shedding in Donors, with transmission to Recipients.
Measured: Day 1 to day 10
Clinical parameters of infection and association with infection transmission.
To explore the association and severity of self-reported influenza symptoms and pyrexia between Recipient groups (intervention vs. no intervention), both cumulatively and by individual symptom type.
To explore the association of self-reported influenza symptoms in Donors, with transmission to Recipients, both cumulatively and by individual symptom type.
Measured: Day 1 to day 10
Environmental disposition of virus during infection.
To determine the environmental dispersion and deposition of the virus (fomites and air) in Exposure rooms and the relationship between (a) virological findings and environmental deposition, (b) symptom scores and environmental deposition, and (c) environmental deposition and SAR in Recipients.
To characterize the exhaled breath particle sizes and aerosolized virus copy numbers expelled by influenza inoculated and influenza exposed volunteers.
Measured: Day 1 to day 10
Safety of experimental infection in both challenged and exposed volunteers.
- Incidence, severity, and relationship of adverse events to challenge virus and/or study procedures.
- Changes in safety laboratory tests, vital signs and clinical tests (electrocardiogram [ECG], spirometry) from baseline
Measured: Day 1 to day 28(±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Retroscreen Virology Ltd., Wake Forest University Health Sciences, University of Maryland, University of Leeds, Building Services Research and Information Association (BSRIA), University College, London, Mount Sinai Hospital, New York, Imperial College London, University of Glasgow, Sydney Children's Hospitals Network
- Responsible party
- Sponsor
- Investigators
- Jonathan S Nguyen-Van-Tam, BM, BS, DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710111
- Sponsor's protocol ID
- 12074
- Acronym
- EMIT
- Status last verified
- Jan 2014
- First submitted
- 9 Oct 2012
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lai J, Bueno de Mesquita PJ, Hong F, Ma T, Cowling BJ, Milton DK. Comparison of Viral Aerosol Shedding by Mild and Moderately Symptomatic Community-Acquired and Nasally Inoculated Influenza A(H3) Infection. Influenza Other Respir Viruses. 2025 Jun;19(6):e70129. doi: 10.1111/irv.70129.
PubMed 40509995Bueno de Mesquita PJ, Noakes CJ, Milton DK. Quantitative aerobiologic analysis of an influenza human challenge-transmission trial. Indoor Air. 2020 Nov;30(6):1189-1198. doi: 10.1111/ina.12701. Epub 2020 Jun 15.
PubMed 32542890
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Modes of Influenza Transmission Using a Human Challenge Model
- ClinicalTrials.gov ID
- NCT01710111
- Acronym / sponsor ID
- EMIT / 12074
- Conditions
- Influenza, Human
- Keywords
- Human challenge model, Quarantine study, Influenza virus, Modes of transmission, Droplet spray, Droplet nuclei, Secondary attack rate, Face shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Retroscreen Virology Ltd., Wake Forest University Health Sciences, University of Maryland, University of Leeds, Building Services Research and Information Association (BSRIA), University College, London, Mount Sinai Hospital, New York, Imperial College London, University of Glasgow, Sydney Children's Hospitals Network
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Recipients Face Shield | Experimental | Device: Intervention Recipients Face ShieldFace shield and repeat hand hygiene measures |
| Control Recipients | No intervention | –No face shield and no repeat hand hygiene measures |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Body Weight: A total body weight ≥50 kg and a Body mass index (BMI) >18 (if BMI is >32, a body fat percentage within WHO and NIH range for gender and age. BMI [kg/m2] = Body weight [kg] ÷ Height2 [m2]
- Contraception: Nonsterilised males must agree to refrain from fathering a child from the point of entering quarantine until the Day 28 follow up visit. Use of one effective form of contraception is acceptable. Sexually active females of childbearing potential must agree to use 2 effective methods of avoiding pregnancy that are deemed to be effective from the point of entry into the quarantine unit until the Day 28 follow up visit. Acceptable forms of effective contraception include:
- Informed Consent: An informed consent document signed and dated by the subject and investigator
- Serosuitability: Serosuitable for challenge virus
Key exclusion criteria (32 listed)
- Smoking: Significant history of any tobacco use at any time (≥ total 10 pack year history, eg. one pack a day for 10 yrs)
- Pregnancy/Lactation: Subjects who are pregnant or nursing, or who have a positive pregnancy test at any point in study
- Previous Medical History: Presence of significant acute or chronic, uncontrolled medical illness, that in the view of Investigator(s)is associated with increased risk of complications of respiratory viral illness
- Pulmonary Function: Abnormal pulmonary function in the opinion of the investigator evidenced by clinically significant abnormalities in spirometry
- Immune: History or evidence of autoimmune disease or known impaired immune responsiveness (of any cause)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Recipients Face ShieldFace shield and repeat hand hygiene measures | Device | Intervention Recipients Face Shield |
Primary outcome
Difference in Secondary Attack Rate (SAR)
Time frame: Day -2 to day 28(±3)
The primary endpoint is the difference in SAR of influenza in Recipients randomised to an intervention arm (face shield and hand hygiene -droplet nuclei transmission only) compared to Recipients randomised to a control arm (no intervention - all modes of transmission).
4 secondary outcomes
Viral parameters of infection and association with infection transmission.
Time frame: Day 1 to day 10
Clinical parameters of infection and association with infection transmission.
Time frame: Day 1 to day 10
Environmental disposition of virus during infection.
Time frame: Day 1 to day 10
Safety of experimental infection in both challenged and exposed volunteers.
Time frame: Day 1 to day 28(±3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Derived from this study: PubMed 40509995Lai J, Bueno de Mesquita PJ, Hong F, Ma T, Cowling BJ, Milton DK. Comparison of Viral Aerosol Shedding by Mild and Moderately Symptomatic Community-Acquired and Nasally Inoculated Influenza A(H3) Infection. Influenza Other Respir Viruses. 2025 Jun;19(6):e70129. doi: 10.1111/irv.70129.
- Derived from this study: PubMed 32542890Bueno de Mesquita PJ, Noakes CJ, Milton DK. Quantitative aerobiologic analysis of an influenza human challenge-transmission trial. Indoor Air. 2020 Nov;30(6):1189-1198. doi: 10.1111/ina.12701. Epub 2020 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Nguyen-Van-Tam, BM, BS, DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Recipients Face Shield in people with Influenza, Human, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Secondary Attack Rate (SAR) (time frame: Day -2 to day 28(±3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.