Evaluating Modes of Influenza Transmission 2b Baseline SAR

NCT07342556 | Not Yet Recruiting

• 2 other identifiers: 2313702-Baseline-SARU19AI162130
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to investigate how influenza transmits from person-to-person. Participation as a healthy "Recipient" in this study involves:

• Home semi-quarantine lasting about 14 days during which the participants must wear an N95 in class and take other precautions
• Daily assessments and clinic visits for 14 days
• Spending every weekday evening for about 14 days from around 6 - 10 pm, including a provided dinner, in a controlled environment. There may be additional sessions and different required participation times on weekends
• Exposure to people infected with influenza in the controlled environment
• Three blood draws, at the start, at the end of 14 days, and about a month after the end.
• A follow-up clinic visits one month after the end of home semi-quarantine
• A two-month follow-up phone call. This study may increase the participant's risk of catching influenza. If the participants get infected during the study, the investigators may:
• Provide the participants with a prescription for antiviral medication or
• Refer the participants for medical care
• Ask the participants to become a Donor and expose other Recipients. The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for an infection resulting from the study, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed. If the participants are someone who recently became infected with influenza either through their daily activities or by participating in this study as a Recipient, they are invited to participate in this research study as a Donor and interact with a group of health participants in a controlled environment. Participation in this study as a Donor involves exposing Recipients for at least one and up to five days including:
• Attend exposure events in a controlled environment
• Weekday evenings from around 6-10 pm
• Additional day and evening events on weekends
• Events include a provided dinner
• Daily assessments and clinic visits for 1 to 5 days
• Provide exhaled breath samples for 30 to 60 minutes
• Three blood draws, at the start and end of exposure events, and about a month after the end
• A follow-up clinic visit one month after their last exposure event
• A two-month follow-up phone call If the participants experience severe symptoms related to their influenza infection, we may:
• Provide the participants with a prescription for antiviral medication or
• Refer the participants for medical care The participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for their influenza infection, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.

Conditions

Influenza (Healthy Volunteers)

Keywords

influenza; airborne transmission; infection transmission; touch transmission; spray (droplet) transmission

Outcome Measures

Primary Outcomes (3)

• PCR confirmed transmission of influenza virus infection

  Transmission of influenza infection defined as having \>1 nasal swab test positive for an influenza virus matching the type and subtype detected in a trial Donor.

  1 month

• Genomic sequencing-confirmed transmission of influenza virus infection

  Sequencing-confirmed transmission will be defined as a Recipient infection with a virus having ≤2 nucleotide difference from the virus infecting a trial Donor and closer genetic relationship to the apparent source Donor than Donors recruited from the community are to each other.

  1 month

• Culture-confirmed transmission of influenza virus infection

  Culture-confirmed transmission will be defined as positive viral culture for a virus that is also a sequence match to a virus cultured from a Donor.

  1 month

Study Arms (1)

Exposure to Donors with naturally acquired influenza infection under controlled conditions

OTHER

Recipients are exposed to Donors in a controlled environment while performing prescribed activities, including playing cards and other games, and periodically shaking hands with Donors and rubbing their own nose and eyes.

Other: Exposure to Donors with naturally acquired influenza virus infection

Interventions

Exposure to Donors with naturally acquired influenza virus infection OTHER

Recipients are exposed to Donors in a controlled environment while performing prescribed activities, including playing cards and other games, and periodically shaking hands with Donors and rubbing their own nose and eyes.

Exposure to Donors with naturally acquired influenza infection under controlled conditions

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Enrolled in the Recipient Registry (UMD IRB Protocol # 2303473, eligible age ≥18 and ≤49)
• Provides written informed consent, can comply with the planned study procedures, is available for an up to \~14-day home semi-quarantine period, and can attend scheduled exposure events and scheduled follow-up visits.
• Participants must be able to comprehend the study requirements, as evidenced by a score of 100% on the comprehension assessment (repeated tries permitted).
• No significant change (for the worse) in general health history or in concomitant medication use, as compared from their responses collected during screening (Recipient Protocol).
• Live in a private, single occupancy bedroom and agree to take precautions to avoid contracting a respiratory infection outside of the controlled exposure events through a home semi-quarantine prescribed by investigators.
• Agree not to meet with other participants (Recipients or Donors) outside of the programmed exposure events during their participation in the home semi-quarantine.

You may not qualify if:

• Female of childbearing potential who has a positive urine pregnancy test within 24 hours of enrollment in a Recipient Cohort or is breastfeeding or planning to become pregnant within 2 months after enrollment.
• Presence of infection with influenza, SARS-CoV-2, or other respiratory pathogens detected via a multiplex nucleic acid amplification test (e.g., TaqMan Array Card assay) at entry to the transmission trial.
• a. Volunteers with influenza infection may be eligible to enroll as Donors.
• Within the past 72 hours, presence of influenza-like illness, as defined as fever of ≥100.2°F AND cough or sore throat, in the absence of an alternative cause.
• Receipt of any blood products within the past 2 months.
• Does not agree to provide permission for secondary research use of extra samples collected and stored specimens.
• Has an ongoing symptomatic condition for which the individual has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. (symptomatic condition means for example ongoing chronic fatigue without a diagnosis for symptom.)
• Presence of self-reported or medically documented significant medical or psychiatric condition(s) Significant medical or psychiatric conditions include but are not limited to:
• Respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\], asthma, cystic fibrosis) requiring daily medications\* currently or any treatment of respiratory disease exacerbations or hospitalizations for acute respiratory illnesses (e.g., asthma exacerbation) in the last 5 years. (\* Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.)
• Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
• Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
• Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.
• An autoimmune disease.
• An immunodeficiency of any cause.
• A blood disorder (e.g., sickle cell disease)

Sponsors & Collaborators

• University of Maryland, College Park: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

Related Publications (2)

• Nguyen-Van-Tam JS, Killingley B, Enstone J, Hewitt M, Pantelic J, Grantham ML, Bueno de Mesquita PJ, Lambkin-Williams R, Gilbert A, Mann A, Forni J, Noakes CJ, Levine MZ, Berman L, Lindstrom S, Cauchemez S, Bischoff W, Tellier R, Milton DK; EMIT Consortium. Minimal transmission in an influenza A (H3N2) human challenge-transmission model within a controlled exposure environment. PLoS Pathog. 2020 Jul 13;16(7):e1008704. doi: 10.1371/journal.ppat.1008704. eCollection 2020 Jul.

  PMID: 32658939 BACKGROUND

• Lai J, Sobhani H, Coleman KK, Tai SS, Hong F, Sierra Maldonado I, Esparza Y, McPhaul KM, Zhu S, DeVoe DL, Ortiz JR, Chen S, Yellin T, Carreno JM, Krammer F, Cowling BJ, Gordon A, Chen WH, Srebric J, Milton DK; EMIT-2 Study Team. Evaluating modes of influenza transmission (EMIT-2): Insights from lack of transmission in a controlled transmission trial with naturally infected donors. PLoS Pathog. 2026 Jan 7;22(1):e1013153. doi: 10.1371/journal.ppat.1013153. eCollection 2026 Jan.

  PMID: 41499634 BACKGROUND

Related Links

• A link for information about volunteering as a healthy participant

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Donald K Milton, MD, DrPH

  University of Maryland School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Esparza, MSN

CONTACT

301-405-3142; yesparza@umd.edu

Isabel Sierra Maldonado, MHA

CONTACT

301-405-3142; itsierra@umd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished University Professor

Model Details: Healthy people "Recipients" will be exposed to people who have recently become naturally infected with influenza virus in a controlled environment designed to maximize all major routes of respiratory viral infection transmission (touch contact, spray direct deposition (previously called droplet), and airborne-inhalation transmission.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be made publicly available at the time of publication of study results and will be published in a permanent (to the extent that the internet is permanent) repository with permanent DOI.
• Access Criteria: Publicly available via a DOI included in publications.

Locations

US (1)