RECRUITING

A/Texas Flu Challenge

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a)

Quick Facts

Study Start:2025-02-04

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06753474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period. * Agrees not to 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 before challenge and through the quarantine period, unless approved by the investigator.	* 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. * Have a body mass index (BMI) less than or equal to 18.5 or greater than or equal to 35. * Smoke more than four cigarettes, e-cigarettes, marijuana, or other tobacco products weekly within 60 days before the challenge. * Have moderate or severe illness within seven days before the challenge. This includes but is not limited to an oral temperature of ≥100°F, diarrhea, or vomiting. * Have a pulse rate of less than 55 beats per minute (bpm) or greater than 100 bpm (participants will not be excluded if the heart rate is 55 bpm with moderate exercise (e.g., walking up two flights of stairs)) * Have a systolic blood pressure of less than 90 mmHg or greater than 140 mmHg on two separate measurements (screening and pre-challenge). * Have a diastolic blood pressure of 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 \[WBC\], absolute neutrophil count \[ANC\], hemoglobin, 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 the study investigator. * Have abnormal findings on screening chest X-ray deemed clinically significant by the study investigator. * Have ongoing drug or alcohol abuse and/or dependence within five years of challenge. * Have positive urine/serum test for drugs of abuse (i.e. cocaine, benzodiazepines, opiates, or metabolites). * Have any medical, psychiatric, occupational, or behavioral problems that could make it difficult for the participant to comply with the protocol as determined by the investigator. * Have received experimental products within 30 days before the challenge or plan to receive experimental products at any time during the study. * Plan to enroll in another clinical trial that could interfere with the 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 study. * Have received a live vaccine within 30 days before the challenge or plan to receive a live vaccine before Day 31 post-challenge. * Have received an inactivated vaccine within 14 days before the challenge or plan to receive an inactivated vaccine before Day 14 of the challenge.

Inclusion Criteria

Exclusion Criteria

* 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.
* Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period.
* Agrees not to 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 before challenge and through the quarantine period, unless approved by the investigator.

* 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.
* Have a body mass index (BMI) less than or equal to 18.5 or greater than or equal to 35.
* Smoke more than four cigarettes, e-cigarettes, marijuana, or other tobacco products weekly within 60 days before the challenge.
* Have moderate or severe illness within seven days before the challenge. This includes but is not limited to an oral temperature of ≥100°F, diarrhea, or vomiting.
* Have a pulse rate of less than 55 beats per minute (bpm) or greater than 100 bpm (participants will not be excluded if the heart rate is 55 bpm with moderate exercise (e.g., walking up two flights of stairs))
* Have a systolic blood pressure of less than 90 mmHg or greater than 140 mmHg on two separate measurements (screening and pre-challenge).
* Have a diastolic blood pressure of 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 \[WBC\], absolute neutrophil count \[ANC\], hemoglobin, 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 the study investigator.
* Have abnormal findings on screening chest X-ray deemed clinically significant by the study investigator.
* Have ongoing drug or alcohol abuse and/or dependence within five years of challenge.
* Have positive urine/serum test for drugs of abuse (i.e. cocaine, benzodiazepines, opiates, or metabolites).
* Have any medical, psychiatric, occupational, or behavioral problems that could make it difficult for the participant to comply with the protocol as determined by the investigator.
* Have received experimental products within 30 days before the challenge or plan to receive experimental products at any time during the study.
* Plan to enroll in another clinical trial that could interfere with the 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 study.
* Have received a live vaccine within 30 days before the challenge or plan to receive a live vaccine before Day 31 post-challenge.
* Have received an inactivated vaccine within 14 days before the challenge or plan to receive an inactivated vaccine before Day 14 of the challenge.

Contacts and Locations

Study Contact

Nadine Rouphael, MD

CONTACT

404-712-1435

nroupha@emory.edu

Principal Investigator

Nadine Rouphael, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital Clinical Research Network

Atlanta, Georgia, 30322

United States

Hope Clinic

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Nadine Rouphael, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02-04

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Influenza