Actively Recruiting

Phase 1
Age: 18Years - 49Years
All Genders
Healthy Volunteers
NCT05332899

Influenza Human Challenge Model

Led by Emory University · Updated on 2026-03-27

80

Participants Needed

2

Research Sites

288 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Influenza Human Challenge Model

Who Can Participate

Age: 18Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before starting any study procedures
  • Able to understand and follow all study procedures
  • Healthy males and non-pregnant, non-breastfeeding females aged 18 to 49 years at enrollment
  • Women of childbearing potential must use birth control or abstain from sex for at least 30 days before enrollment through the study duration
  • Negative pregnancy test at screening and within 24 hours before flu virus challenge
  • In good general health without chronic lung, heart, immune, neurological, autoimmune, or inflammatory diseases as determined within 30 days of challenge
  • Must score at least 70% on a quiz about the study protocol and policies
  • Agree not to use tobacco products during quarantine
  • Agree not to use medications that could affect flu symptoms or challenge efficacy within 14 days before and during quarantine unless approved by the investigator
Not Eligible

You will not qualify if you...

  • Contact with children under 5 years, children or teens on long-term aspirin, pregnant women, persons over 65, or those with significant chronic illnesses
  • Healthcare workers with patient contact within 2 weeks after flu challenge
  • Planning to live in confined spaces (e.g., ship, camp, dorm) within 2 weeks after challenge
  • Pregnant or planning pregnancy during the study
  • Breastfeeding or planning to breastfeed during the study
  • Body mass index ≤18.5 or ≥35
  • Smoking more than 4 tobacco products per week within 60 days before challenge
  • Recent moderate/severe illness or fever ≥100°F, diarrhea, or vomiting within 7 days before challenge
  • Abnormal heart rate, blood pressure, or certain medication use
  • Active HIV, hepatitis B or C infection
  • Abnormal lab tests or significant findings on ECG or chest X-ray
  • Drug abuse history or positive drug tests (except certain exceptions)
  • Medical, psychiatric, occupational, or behavioral problems affecting study compliance
  • Recent or planned use of experimental products, vaccines, or blood products within specified timeframes
  • Known recent contact with someone with influenza
  • Known severe allergies to flu drugs, multiple antibiotics, or severe egg allergy
  • Any condition judged by the investigator as unsafe or impairing informed consent
  • Positive respiratory pathogen test on day of admission
  • Significant lung function abnormalities if applicable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hope Clinic

Atlanta, Georgia, United States, 30030

Actively Recruiting

2

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

N

Nadine Rouphael, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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