Influenza Human Challenge Model

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
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• Provide written informed consent prior to initiation of any study procedures.

• Are able to understand and comply with all planned study procedures.

• Healthy males and non-pregnant, non-breast-feeding females aged ≥18 and ≤49 years of age inclusive at enrollment.

• Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through the duration of the trial. Male subjects must agree not to father a child for the duration of the trial.

• Women of childbearing potential must have a negative serum or urine pregnancy test at screening and negative urine pregnancy test within 24 hours prior to challenge.

• Are in good general health, as determined by the study investigator within 30 days of challenge and do not have any of the following conditions:

‣ Chronic pulmonary disease (e.g., asthma or reactive airway disease, emphysema)

⁃ Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)

⁃ Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies)

⁃ Immunosuppression or ongoing malignancy or history of malignancy (excluding nonmelanotic skin cancer in remission without treatment for more than 5 years)

⁃ Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)

⁃ History of postinfectious or postvaccine neurological sequelae

⁃ Autoimmune, inflammatory, vasculitic or rheumatic disease, including but not limited to systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis or scleroderma

• Demonstrate knowledge and comprehension of the study by scoring ≥70% on a quiz of the study protocol and policies.

• Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period.

• Agrees to not use prescription or over-the-counter medications that could impact influenza challenge efficacy or symptoms (including oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine and rimantadine, aspirin, intranasal steroids, acetaminophen, decongestants, antihistamines, and other NSAIDs), within 14 days prior to quarantine and through the quarantine period, unless approved by the investigator.

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Hope Clinic
RECRUITING
Atlanta
Contact Information
Primary
Nadine Rouphael, MD
nroupha@emory.edu
404-712-1435
Time Frame
Start Date: 2022-05-24
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Experimental: Influenza Challenge Model with Influenza A H3N2 Strain
Participants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2).
Related Therapeutic Areas
Sponsors
Leads: Emory University

This content was sourced from clinicaltrials.gov

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