Actively Recruiting

Phase 1
Age: 18Years - 49Years
All Genders
Healthy Volunteers
NCT06753474

A/Texas Flu Challenge

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

50

Participants Needed

2

Research Sites

147 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

NATIONAL PHILANTHROPIC TRUST

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body's immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), clade 3C3a produced specifically for clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy participants. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Study volunteers will be recruited and screened from the general population of metro Atlanta through advertisements or identified from a database of research participants who have previously agreed to be contacted for future research studies. Participants will provide written consent before study participation. Up to 200 healthy adults, 18-49 years old, will be screened for participation. Eligible participants will take part in the study over 5 months. Enrolled participants will be admitted to Emory University Hospital during which time they will receive the influenza virus in the form of a spray in the nose or exposure to infected participants followed by an 8-12 day inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center. Participants will receive compensation (pro-rated for all visits completed) for their time and effort. There will be no costs to participants as a result of being in the study.

CONDITIONS

Official Title

A/Texas Flu Challenge

Who Can Participate

Age: 18Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and follow all study procedures
  • Healthy, non-pregnant, non-breastfeeding adults aged 18 to 49 years
  • Persons biologically able to become pregnant must use acceptable birth control or practice abstinence from 30 days before challenge through the study
  • Negative pregnancy test at screening and within 24 hours before challenge for persons of childbearing potential
  • Good general health without significant chronic diseases, neurological conditions, immunosuppression, or autoimmune disorders
  • Score 70% or higher on a study knowledge quiz
  • Agree to avoid tobacco, marijuana, and related products during quarantine
  • Agree not to use certain medications that could affect flu symptoms or study outcomes 14 days before challenge and during quarantine unless approved by the investigator
Not Eligible

You will not qualify if you...

  • Living with or having daily contact with children under 5 years or pregnant persons
  • Having chronic pulmonary or cardiovascular diseases, or other significant chronic medical conditions requiring close follow-up
  • Healthcare workers with patient contact during two weeks after flu challenge
  • Planning to live in confined environments during two weeks after challenge
  • Pregnant or planning to become pregnant during the study
  • Breastfeeding or planning to breastfeed during the study
  • Body mass index 18.5 or lower, or 35 or higher
  • Smoking more than four tobacco or marijuana products weekly within 60 days before challenge
  • Moderate or severe illness within 7 days before challenge, including fever, diarrhea, or vomiting
  • Heart rate less than 55 or greater than 100 beats per minute
  • Abnormal blood pressure readings at screening and pre-challenge
  • Long-term use of high-dose steroids or glucocorticoids
  • Active HIV, hepatitis B, or hepatitis C infection
  • Abnormal laboratory test results or clinically significant findings on ECG or chest X-ray
  • Drug or alcohol abuse within 5 years or positive drug tests (except THC or prescribed medications)
  • Medical, psychiatric, occupational, or behavioral issues that could affect study compliance
  • Use of experimental products within 30 days before challenge or during the study
  • Participation in other clinical trials that could interfere with safety assessment
  • Planning to donate blood during the study
  • Receipt of live vaccine within 30 days before challenge or planned before Day 31 post-challenge
  • Receipt of inactivated vaccine within 14 days before challenge or planned before Day 14 post-challenge

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

Emory University Hospital Clinical Research Network

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Hope Clinic

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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