A/Texas Flu Challenge

NCT06753474 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY000083712025P011799
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Number of participants with mild to moderate influenza disease

  Number of participants with mild to moderate influenza disease (MMID) from challenge through discharge from quarantine.

  Up to Day 12

• 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 Day 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)

Live Influenza Virus RG-A/Texas/71/2017 (H3N2

EXPERIMENTAL

Participants will be pre-screened up to sixty days before the challenge study to identify baseline HAI titer. Participants will either be in the intranasal challenge or the natural exposure cohort.

Biological: Influenza Virus influenza A H3N2 strain

Interventions

Influenza Virus influenza A H3N2 strain BIOLOGICAL

Live Influenza Virus RG-A/Texas/71/2017 (H3N2). It is a cell-grown, reverse genetics-derived influenza A virus manufactured to conduct clinical trials that involve controlled human infection with influenza A virus. This influenza human challenge virus was produced for the National Institute of Allergy and Infectious Diseases (NIAID). The final Drug Product Live Influenza Virus RG-A/Texas/71/2017 (H3N2) (Lot #1507-232149) vial contains 1.86 X 106 median tissue culture infectious doses (TCID50)/mL formulated in 1X sucrose-phosphate-glutamate (SPG; 7.4% sucrose, 3.8 mM KH2PO4, 7.2 mM K2HPO4, 5.4 mM L-glutamic acid) in Ex-Cellä 293 serum-free medium (Sigma-Aldrich). It is susceptible to the FDA-approved neuraminidase (NA) inhibitors (NAI) oseltamivir phosphate, zanamivir, and peramivir, and the polymerase acidic (PA) inhibitor (PAI) baloxavir marboxil.x

Also known as: RG-A/Texas/71/2017 H3N2

Live Influenza Virus RG-A/Texas/71/2017 (H3N2

Eligibility Criteria

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

You may qualify if:

• 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 such as condoms or diaphragms with spermicide or foam, effective devices (IUDs, NuvaRing®) or licensed hormonal products such as implants, injectables or oral contraceptives.
• Persons of childbearing potential must have a negative serum or urine pregnancy test at screening and a negative urine pregnancy test within 24 hours before 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 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, ongoing malignancy, or history of malignancy (excluding non-melanotic 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, vasculitis, 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 on the study protocol and policies.

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.
• Persons 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 (e.g., asthma, emphysema, COPD).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or cancer.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Healthcare workers with patient contact during the two weeks following the influenza challenge.
• Plan to live in a confined environment (e.g., ship, camp, or dormitory) during the two weeks following the influenza challenge.
• Pregnant persons or are planning to become pregnant at any time during the study.
• Persons who are breastfeeding or plan to breastfeed at any time during the study.

Sponsors & Collaborators

• Emory University: lead
• NATIONAL PHILANTHROPIC TRUST: collaborator

Study Sites (2)

Emory University Hospital Clinical Research Network

Atlanta, Georgia, 30322, United States

RECRUITING

Hope Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

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 of Medicine

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available for sharing one year after the results from this study are published.
• Access Criteria: Data will be made available for sharing with researchers who provide a methodologically sound protocol, to achieve the aims stated in the protocol. The proposal should be directed to nroupha@emory.edu. Requestors will need to sign a data access agreement.

Locations

US (2)