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Virus Therapy

Flu Challenge Study

Phase 1
Recruiting
Led By Nadine Rouphael, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy males and non-pregnant, non-breast-feeding females aged ≥18 and ≤49 years of age inclusive at enrollment
Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period
Must not have
Have household contact with or have daily contact with: Children under 5 years of age, Children and/or teenagers who are receiving long-term aspirin therapy, Women who are pregnant or who are trying to become pregnant, Persons older than 65 years of age, Persons of any age with significant chronic medical conditions such as: chronic pulmonary disease, chronic cardiovascular disease, contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease, immunosuppression or cancer, neurological and neurodevelopmental conditions
Timeline
Screening 1 month
Treatment Varies
Follow Up baseline, day 28
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how our bodies respond to the flu, and how the virus is transmitted. They will use a safe, controlled form of the flu virus, and expect mild to moderate symptoms.

Who is the study for?
Healthy adults aged 18-49 who can follow study procedures and are not pregnant, breastfeeding, or planning to become pregnant. They must use birth control if applicable, avoid certain medications before and during the trial, not smoke or use tobacco products, and have no chronic diseases like asthma or heart conditions.
What is being tested?
The trial is testing how people's immune systems respond to a controlled flu virus infection (H3N2 strain) and how this virus spreads in an environment. It aims to understand the body's defense mechanisms against flu and assesses the safety of exposing healthy individuals to this specific flu strain.
What are the potential side effects?
Participants may experience mild to moderate flu symptoms such as fever, coughing, congestion, muscle aches, fatigue due to exposure to H3N2 influenza challenge virus based on previous studies with this strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult between 18 and 49 years old and not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am in close contact with vulnerable individuals, including young children, pregnant women, elderly, or those with chronic conditions.

Timeline

Screening ~ 1 month
Treatment ~ Varies
Follow Up ~baseline, day 28
This trial's timeline: 1 month for screening, Varies for treatment, and baseline, day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Mild to Moderate Influenza Disease
Number of Participants with Severe Influenza Disease
Number of Serious Adverse Events
Secondary study objectives
Change in Geometric Mean Fold Rise (GMFR) of HAI
Change in Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI)
Change in Number of Participants with 4-fold Rise in HAI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Influenza Challenge Model with Influenza A H3N2 StrainExperimental Treatment1 Intervention
Participants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2).

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,458 Total Patients Enrolled
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
847 Total Patients Enrolled

Media Library

Influenza Virus Type A H3N2 Challenge (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05332899 — Phase 1
Healthy Subjects Research Study Groups: Influenza Challenge Model with Influenza A H3N2 Strain
Healthy Subjects Clinical Trial 2023: Influenza Virus Type A H3N2 Challenge Highlights & Side Effects. Trial Name: NCT05332899 — Phase 1
Influenza Virus Type A H3N2 Challenge (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05332899 — Phase 1
~2 spots leftby Mar 2025
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