Evaluating Modes of Influenza Transmission 2b Baseline SAR

NCT07342556 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-15

No results posted yet for this study

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)

Interventions

OTHER

Exposure to Donors with naturally acquired influenza virus infection

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • University of Maryland, College Park

    lead OTHER

Principal Investigators

  • Donald K Milton, MD, DrPH · University of Maryland School of Public Health

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-03-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342556 on ClinicalTrials.gov