Recruiting

Phase 1

Influenza ChallengeInfluenza Human Challenge Model

Sponsor:

Emory University

Code:

NCT05332899

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Influenza Virus Type A H3N2 Challenge

Study Details

Brief 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.

Conditions

Influenza

Study ID

NCT05332899

Start date

May 24, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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
Are healthcare workers with patient contact in the 2 weeks after influenza challenge.
Plan to be living in a confined environment (e.g. ship, camp, or dormitory) within 2 weeks after receiving the challenge strain.
For females, are pregnant or plan to become pregnant at any time between the Screening Visit through the duration of the trial.
Are breastfeeding or plan to breastfeed at any given time throughout the study.
Have a body mass index (BMI) less than or equal to 18.5 and greater than or equal to 35.
Smoke more than 4 cigarettes, e-cigarettes, marijuana, or other tobacco products on weekly basis within 60 days prior to challenge.
Have moderate or severe illness and/or an oral temperature ≥100°F and/or diarrhea or vomiting within seven days prior to challenge.
Have a pulse rate less than 55 beats per minute (bpm) or >100 bpm. If heart rate is <55 bpm and the investigator determines that this is not clinically significant (e.g., athletes) and heart rate increases >55 bpm on moderate exercise (two flights of stairs), subject will not be excluded.
Have a systolic blood pressure less than 90 mmHg or greater than 140 mmHg on two separate measurements (screening and pre-challenge).
Have a diastolic blood pressure less than 50 mmHg or greater than 90 mmHg on two separate measurements (screening and pre-challenge).
Have long-term (≥2 weeks) use of high-dose oral (≥20 mg per day prednisone or equivalent) or parenteral glucocorticoids, or high-dose inhaled steroids for greater than 7 days in the last 3 months.
Have an active HIV, hepatitis B, or hepatitis C infection.
Have screening laboratory test results (white blood cells (WBCs), absolute neutrophil count (ANC), hemoglobin (Hgb), platelets) that are outside the laboratory reported normal values and deemed clinically significant by the study investigator.
Have a serum creatinine greater than 1.1 x upper limit of normal (ULN).
Have an alanine aminotransferase (ALT) greater than 1.1 x ULN.
Have abnormal findings on screening electrocardiogram deemed clinically significant by study investigator.
Have abnormal findings on screening chest X-ray deemed clinically significant by study investigator.
Have ongoing drug abuse/dependence (including alcohol), or a history of these issues within 5 years of enrollment.
Have positive urine/serum test for drugs of abuse (i.e. cocaine, benzodiazepines, opiates, or metabolites). Positive results for tetrahydrocannabinol (THC) will not be considered exclusionary. Metabolites and amphetamines as prescribed for a documented medical condition will also not be considered exclusionary.
Have any medical, psychiatric, occupational, or behavioral problems that could make it difficult for the subject to comply with the protocol as determined by the investigator.
Have received experimental products within 30 days before study entry or plan to receive experimental products at any time during the study.
Plans to enroll in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period, including study interventions such as drugs, biologics or devices.
Plan to donate blood during the course of the study.
Have received a live vaccine within 30 days before study entry or plan to receive a live vaccine prior to Day 31 of the challenge.
Have received an inactivated vaccine within 14 days before study entry or plan to receive an inactivated vaccine prior to Day 14 of the challenge.
Have received parenteral immunoglobulin or blood products within 3 months of the study start, or plan to receive parenteral immunoglobulin or blood products for the duration of the study.
Have a known close contact with anyone known to have influenza in the past 7 days prior to screening or challenge.
Have a known history of allergy to anti-influenza drugs, more than 2 classes of antibiotics or severe egg allergy.
Have any condition that, in the judgment of the study investigator, is a contraindication to protocol participation or impairs the subject's ability to give informed consent.
Have a BIOFIRE® FILMARRAY® respiratory panel that identifies any pathogen on the day of admission.
Clinically significant abnormality as deemed by the study investigator on the PFT and/or spirometry at screening visit (if applicable, for inhalation challenge only.)

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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).

Interventions

Influenza Virus Type A H3N2 Challenge

The intervention product is a live challenge virus that is manufactured in the USA under Good Manufacturing Practice (GMP). The challenge will be administered intranasally using a sprayer device, by natural exposure to infected participants, by inhalation from an aerosol generator or nebulizer, or by inhalation within a tent. Participants will be admitted to the hospital and quarantined for 8 to 12 days for monitoring, and will receive care and supportive treatment as necessary. Participants will be followed for a total of 12 weeks.

Primary outcome measure

Number of Participants with Mild to Moderate Influenza Disease [ Time Frame: Up to Day 8 ]
Number of Serious Adverse Events [ Time Frame: Up to Week 12 ]
Number of Participants with Severe Influenza Disease [ Time Frame: Up to Week 12 ]

Central Contacts and Locations

Central contacts

Nadine Rouphael, MD

404-712-1435 nroupha@emory.edu

Locations

Hope Clinic

Recruiting

Atlanta, Georgia, United States, 30030

Contacts

Nadine Rouphael, MD

(404) 712-1435 nroupha@emory.edu

Principal Investigator:

Nadine Rouphael, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nadine Rouphael, MD

(404) 712-1435 nroupha@emory.edu

Principal Investigator:

Nadine Rouphael, MD

More Information

Sponsor

Emory University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.