Influenza
Conditions
Brief summary
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
Interventions
BEHAVIORALPersonal Protective Equipment (PPE) - Under High Air Hygiene
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. High air hygiene is achieved by filtration and/or use of germicidal UV-C.
BEHAVIORALNo Intervention - Under High Air Hygiene
No intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C.
BEHAVIORALPersonal Protective Equipment (PPE) - Under Low Air Hygiene
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. Low air hygiene is achieved with minimal ventilation.
BEHAVIORALNo Intervention - Under Low Air Hygiene
No intervention Low air hygiene is achieved with minimal ventilation.
Sponsors
University of Maryland, College Park
National Institute of Allergy and Infectious Diseases (NIAID)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
For Donors: Inclusion Criteria: * Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits. * Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted). * Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent. \*Pregnancy and breastfeeding status to be determined by self-report * Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event. \*A rapid antigen test in the setting of known local influenza activity and with symptoms suggestive of influenza at that time is acceptable * Within the past 48 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat, or onset of less specific symptoms with a positive molecular test for influenza virus infection * No self-reported or known history of alcohol or drug abuse within the past two years and no illicit drug use within the last 30 days. * Do not have clinically significant medical, psychiatric, and chronic or intermittent health conditions including those listed in
Exclusion criteria
. * Does not have an ongoing symptomatic condition for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. \*e.g., ongoing and debilitating fatigue without a diagnosis for the symptom. * Agrees to the collection of specimens for secondary research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Confirmation | 2 weeks | Proportion of recipients with viral confirmation of influenza infection |
| Symptomatic Confirmation | 2 weeks | Proportion of recipients with symptomatic confirmation of influenza infection |
| Serological Confirmation | 2 weeks | Proportion of recipients with serological confirmation of influenza infection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Donors Donors are persons naturally infected with influenza. | 6 |
| Control Recipients Control recipients are participants who do not have influenza and will not be using personal protective equipment. | 28 |
| Total | 34 |
Baseline characteristics
| Characteristic | Donors | Control Recipients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 28 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 26 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Influenza Symptoms Score | 6 Participants | 28 Participants | 34 Participants |
| Nasal Swab | 6 Participants | 28 Participants | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 14 Participants | 16 Participants |
| Serum HAI and FRNT antibody titers | 6 Participants | 28 Participants | 34 Participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 1 Participants | 17 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 28 |
| other Total, other adverse events | 1 / 6 | 10 / 28 |
| serious Total, serious adverse events | 0 / 6 | 0 / 28 |
Outcome results
Primary
Serological Confirmation
Proportion of recipients with serological confirmation of influenza infection
Time frame: 2 weeks
Population: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donors | Serological Confirmation | 6 Participants |
| Control Recipients | Serological Confirmation | 0 Participants |
Primary
Symptomatic Confirmation
Proportion of recipients with symptomatic confirmation of influenza infection
Time frame: 2 weeks
Population: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donors | Symptomatic Confirmation | 6 Participants |
| Control Recipients | Symptomatic Confirmation | 0 Participants |
Primary
Viral Confirmation
Proportion of recipients with viral confirmation of influenza infection
Time frame: 2 weeks
Population: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Donors | Viral Confirmation | 6 Participants |
| Control Recipients | Viral Confirmation | 0 Participants |