Influenza Human Challenge Model

NCT05332899 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: STUDY000000832025P013079
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Mild to Moderate Influenza Disease

  The number of participants experiencing mild to moderate influenza disease (MMID) from challenge to discharge from quarantine.

  Up to Day 8

• Number of Serious Adverse Events

  The number of serious adverse events during the duration of the study will be evaluated.

  Up to Week 12

• Number of Participants with Severe Influenza Disease

  The number of participants experiencing severe influenza disease (MMID) from challenge to discharge from quarantine.

  Up to Week 12

Secondary Outcomes (3)

• Change in Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI)

  Baseline, Day 28

• Change in Geometric Mean Fold Rise (GMFR) of HAI

  Baseline, Day 28

• Change in Number of Participants with 4-fold Rise in HAI

  Baseline, Day 28

Study Arms (1)

Influenza Challenge Model with Influenza A H3N2 Strain

EXPERIMENTAL

Participants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2).

Biological: Influenza Virus Type A H3N2 Challenge

Interventions

Influenza Virus Type A H3N2 Challenge BIOLOGICAL

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.

Also known as: A/Perth/16/2009 H3N2

Influenza Challenge Model with Influenza A H3N2 Strain

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Hope Clinic

Atlanta, Georgia, 30030, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Related Publications (1)

• Shetty N, Shephard MJ, Rockey NC, Macenczak H, Traenkner J, Danzy S, Vargas-Maldonado N, Arts PJ, Le Sage V, Anderson EJ, Lyon GM, Fitts EC, Gulick DA, Mehta AK, El-Chami MF, Kraft CS, Wigginton KR, Lowen AC, Marr LC, Rouphael NG, Lakdawala SS. Influenza virus infection and aerosol shedding kinetics in a controlled human infection model. J Virol. 2024 Dec 17;98(12):e0161224. doi: 10.1128/jvi.01612-24. Epub 2024 Nov 26.

  PMID: 39589151 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Rouphael, MD

CONTACT

404-712-1435; nroupha@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: May 24, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available for sharing immediately after the results from this study are published and ending 5 years following publication.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound protocol, for the purpose of achieving the aims stated in the protocol. Proposal should be directed to nroupha@emory.edu. Requestors will need to sign a data access agreement.

Locations

US (2)