InfluenzaPhase 1NCT06753474
A/Texas Flu Challenge
A Phase 1 study testing Influenza Virus influenza A H3N2 strain in people with Influenza, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Virus influenza A H3N2 strain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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:
Show all 37Show fewer
- 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).
- 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 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital Clinical Research Network
Atlanta, Georgia, 30322
- Recruiting
Hope Clinic
Atlanta, Georgia, 30322
About this study
Official title: Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a)
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.
Read more
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.
Read the detailed description
Influenza A continues to circulate widely in the human population and causes significant morbidity and mortality. Current vaccines have variable effectiveness year-to-year, with observable breakthrough infections each season, and have limited effectiveness in certain at-risk members of the population. Although basic and clinical influenza research has broadened our understanding of viral immunology, transmission, and pathogenesis, important questions, particularly concerning correlates of protection, viral evolution, and transmission, remain unanswered. Many of these questions can only be approached through studies in humans.
As more broadly protective vaccines are developed, efficient and comprehensive methods of determining their value will be imperative. One of the key components and gap-filling measures in the National Institute of Allergy and Infectious Diseases (NIAID) strategic plan for universal influenza vaccines is to expand our capacity to conduct human challenge studies with relevant influenza challenge viruses to facilitate early evaluation of new vaccines and to further our understanding of flu pathogenesis and immunity. The goal of this study is to conduct a human challenge study to build upon our success at establishing the influenza challenge model at Emory to better understand influenza pathogenesis, immunity, transmission, and evolution using an H3N2 challenge stock.
Human challenge studies for influenza are a particularly attractive modality for the development of a universal influenza vaccine. As outlined by NIAID's strategic plan, a universal flu vaccine would be at least 75% effective, maintain protection for at least one year, protect against group I (e.g., H1, H5) and II (e.g., H3, H7) influenza A virus strains, and be effective for all age groups. ix The strategic plan also states that a human challenge model could offer unique benefits to better understand the concept of imprinting, determine correlates of protection against influenza, and evaluate different universal influenza vaccine candidates. The development of universal vaccine strategies that reduce transmission potential and can protect from infection by aerosolized viruses will be a strategic advantage for reducing the public health burden from influenza viruses.
- Conditions
- Influenza
- Being tested
- Influenza Virus influenza A H3N2 strain
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus influenza A H3N2 strainBiological
Also called RG-A/Texas/71/2017 H3N2
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Influenza Virus influenza A H3N2 strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 12
Number of Serious Adverse Events
The number of serious adverse events during the duration of the study will be evaluated.
Measured: 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
Measured: Up to Day 12
Secondary outcomes (3)
Change in Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI)
The GMT of HAI to the challenge H3N2 strain will be evaluated.
Measured: Baseline, Day 28
Change in Geometric Mean Fold Rise (GMFR) of HAI
The GMFR of HAI to the challenge H3N2 strain will be evaluated.
Measured: Baseline, Day 28
Change in Number of Participants with 4-fold Rise in HAI
The number of participants with a 4-fold rise in HAI will be evaluated.
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start4 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- NATIONAL PHILANTHROPIC TRUST
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753474
- Sponsor's protocol ID
- STUDY00008371
- Other IDs
- 2025P011799
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available for sharing including data on safety, participant demographics, and immunogenicity.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Human Challenge Model Using H3N2 (A/Texas/71/2017 (H3N2), Clade 3C3a)
- ClinicalTrials.gov ID
- NCT06753474
- Acronym / sponsor ID
- STUDY00008371
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- NATIONAL PHILANTHROPIC TRUST
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Influenza A continues to circulate widely in the human population and causes significant morbidity and mortality. Current vaccines have variable effectiveness year-to-year, with observable breakthrough infections each season, and have limited effectiveness in certain at-risk members of the population. Although basic and clinical influenza research has broadened our understanding of viral immunology, transmission, and pathogenesis, important questions, particularly concerning correlates of protection, viral evolution, and transmission, remain unanswered. Many of these questions can only be approached through studies in humans.
As more broadly protective vaccines are developed, efficient and comprehensive methods of determining their value will be imperative. One of the key components and gap-filling measures in the National Institute of Allergy and Infectious Diseases (NIAID) strategic plan for universal influenza vaccines is to expand our capacity to conduct human challenge studies with relevant influenza challenge viruses to facilitate early evaluation of new vaccines and to further our understanding of flu pathogenesis and immunity. The goal of this study is to conduct a human challenge study to build upon our success at establishing the influenza challenge model at Emory to better understand influenza pathogenesis, immunity, transmission, and evolution using an H3N2 challenge stock.
Human challenge studies for influenza are a particularly attractive modality for the development of a universal influenza vaccine. As outlined by NIAID's strategic plan, a universal flu vaccine would be at least 75% effective, maintain protection for at least one year, protect against group I (e.g., H1, H5) and II (e.g., H3, H7) influenza A virus strains, and be effective for all age groups. ix The strategic plan also states that a human challenge model could offer unique benefits to better understand the concept of imprinting, determine correlates of protection against influenza, and evaluate different universal influenza vaccine candidates. The development of universal vaccine strategies that reduce transmission potential and can protect from infection by aerosolized viruses will be a strategic advantage for reducing the public health burden from influenza viruses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live Influenza Virus RG-A/Texas/71/2017 (H3N2 | Experimental | Biological: Influenza Virus influenza A H3N2 strainParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
- 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:
Key exclusion criteria (37 listed)
- Have household contact with or have daily contact with:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Virus influenza A H3N2 strainAlso: RG-A/Texas/71/2017 H3N2Live 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 | Biological | Live Influenza Virus RG-A/Texas/71/2017 (H3N2 |
Primary outcome
Number of participants with mild to moderate influenza disease
Time frame: Up to Day 12
Number of participants with mild to moderate influenza disease (MMID) from challenge through discharge from quarantine.
Number of Serious Adverse Events
Time frame: Up to Week 12
The number of serious adverse events during the duration of the study will be evaluated.
Number of Participants with Severe Influenza Disease
Time frame: Up to Day 12
The number of participants experiencing severe influenza disease (MMID) from challenge to discharge from quarantine
3 secondary outcomes
Change in Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI)
Time frame: Baseline, Day 28
Change in Geometric Mean Fold Rise (GMFR) of HAI
Time frame: Baseline, Day 28
Change in Number of Participants with 4-fold Rise in HAI
Time frame: Baseline, Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be available for sharing including data on safety, participant demographics, and immunogenicity.
Related trials for Influenza
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Rouphael, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza Virus influenza A H3N2 strain in people with Influenza, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Rouphael, MD (404-712-1435, nroupha@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mild to moderate influenza disease (time frame: Up to Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.