Actively Recruiting
Influenza Human Challenge Model Using H3N2 ATexas712017, Clade 3C3a
Led by Emory University · Updated on 2026-03-03
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
NATIONAL PHILANTHROPIC TRUST
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the immune system responds to influenza and how the flu virus spreads in the environment to help develop better vaccines and treatments. This study focuses on the H3N2 influenza virus strain ATexas712017 clade 3C3a, produced for controlled human infection research. The study will also evaluate the safety of this flu challenge in healthy adults aged 18 to 49, expecting mild to moderate symptoms based on previous data. Participants will be screened and enrolled from the general population and divided into groups receiving the flu virus either through a nasal spray or exposure to infected individuals. The study involves an 8 to 12 day inpatient stay at Emory University Hospital for close observation after exposure. Following this, participants will attend outpatient follow-up visits at the Emory Vaccine Center. Compensation is provided, and there are no costs to participants. During the study, participants will undergo clinical monitoring including assessment of flu symptoms and safety events up to 12 days after infection, with serious adverse events tracked up to 12 weeks. Immune responses will be measured by blood tests before and 28 days after exposure. Participants must comply with study procedures and attend all visits over about 5 months. Researchers aim to understand flu pathogenesis, immunity, transmission, and evolution using this controlled human challenge model.
CONDITIONS
Brief Title
A/Texas Flu Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow all study procedures
- Healthy, non-pregnant, non-breastfeeding persons aged 18 to 49 years
- Persons able to become pregnant must use effective birth control or abstinence from 30 days before challenge through the study
- Negative pregnancy tests for persons of childbearing potential at screening and within 24 hours before challenge
- Good general health without chronic lung, heart, metabolic, immune, neurological, autoimmune, or rheumatic diseases
- Score at least 70% on a study protocol knowledge quiz
- Agree not to use tobacco or certain medications that affect flu symptoms during quarantine
You will not qualify if you...
- Household contact with children under 5 or children/teens on long-term aspirin therapy
- Contact with pregnant persons or persons trying to become pregnant
- Contact with persons over 65 or with chronic medical conditions
- Healthcare workers with patient contact within 2 weeks after challenge
- Planning to live in confined environments during 2 weeks after challenge
- Pregnant or breastfeeding persons or planning pregnancy during study
- BMI less than or equal to 18.5 or greater than or equal to 35
- Smoking more than four tobacco or similar products weekly within 60 days before challenge
- Moderate or severe illness within 7 days before challenge
- Heart rate, blood pressure outside specified ranges
- Long-term use of high-dose steroids
- Active HIV, hepatitis B or C infection
- Abnormal lab tests, chest X-ray, or ECG findings deemed significant
- Drug or alcohol abuse within 5 years
- Positive drug tests except for certain prescribed medications or THC
- Medical, psychiatric, or behavioral issues that affect protocol compliance
- Recent use or planned use of experimental products or vaccines
- Planning to donate blood during study
- Recent live or inactivated vaccines before challenge or planned vaccination within specified days after challenge
Research Team
N
Nadine Rouphael, MD
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