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RecruitingPhase 1NCT06753474

A/Texas Flu Challenge

◆ AI Clinical Summary

This research study exposes healthy volunteers to the flu virus in a controlled setting to help scientists understand how the body's immune system fights the infection and how flu spreads. By participating, you'll help researchers develop better flu vaccines and treatments to protect people in the future.

Key Objective:The trial aims to advance the development of improved flu vaccines and antiviral drugs by studying immune system responses to influenza infection.

Who to Consider:Healthy adults who are willing to be deliberately exposed to the flu virus under medical supervision and can commit to the study's monitoring requirements should consider enrolling.

Trial Parameters

ConditionInfluenza
SponsorEmory University
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment50
SexALL
Min Age18 Years
Max Age49 Years
Start Date2025-02-04
Completion2027-12
Interventions
Influenza Virus influenza A H3N2 strain

Eligibility Fast-Check

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Can understand and comply with all planned study procedures. * Healthy, non-pregnant, non-breast-feeding persons aged ≥18 and ≤49 years of age inclusive at the time of challenge. * Persons biologically able to become pregnant must be practicing abstinence or using an acceptable method of birth control for at least 30 days before the challenge through the duration of the trial. Persons biologically able to make someone pregnant must agree not to get their partner pregnant for the duration of the trial. * A person is considered of childbearing potential unless post-menopausal (absence of menses for ≥1 year) or surgically sterilized (tubal ligation/salpingectomy, bilateral oophorectomy, or hysterectomy). * Acceptable contraception methods for persons of childbearing potential include but are not limited to: sexual abstinence from intercourse with partners biologically able to make them pregnant, monogamous relationship with a vasectomized partner, barrier methods suc

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