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Influenza Human Challenge Model

NCT05332899 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-27

No results posted yet for this study

Summary

This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Type A H3N2 Challenge

The intervention product is a live challenge virus that is manufactured in the USA under Good Manufacturing Practice (GMP). The challenge will be administered intranasally using a sprayer device, by natural exposure to infected participants, by inhalation from an aerosol generator or nebulizer, or by inhalation within a tent. Participants will be admitted to the hospital and quarantined for 8 to 12 days for monitoring, and will receive care and supportive treatment as necessary. Participants will be followed for a total of 12 weeks.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

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
2022-05-24
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05332899 on ClinicalTrials.gov