InfluenzaPhase 1NCT05332899
Influenza Human Challenge Model
A Phase 1 study testing Influenza Virus Type A H3N2 Challenge in people with Influenza, run by Emory University at 2 sites in United States.
Trial 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. 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 Type A H3N2 Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2022to 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
- 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:
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- 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.
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
- 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
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- 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.)
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
Hope Clinic
Atlanta, Georgia, 30030
Nadine Rouphael, MD, (404) 712-1435, nroupha@emory.edu
Nadine Rouphael, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Nadine Rouphael, MD, (404) 712-1435, nroupha@emory.edu
Nadine Rouphael, MD
About this study
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.
Read the detailed description
Influenza continues to cause a significant burden of disease globally and in the United States. In the United States alone, it's estimated that in the 2017-2018 season there were 959,000 hospitalizations related to influenza illness, and 79,400 deaths. Worldwide, the World Health Organization (WHO) estimates that annual influenza epidemics cause 3-5 million cases of severe disease, with 290,000-650,000 of these severe cases resulting in death. Although annual influenza immunizations are recommended and antivirals are available, both have several limitations. The efficacy of the seasonal influenza vaccine is compromised by several factors: antigenic changes over time (requiring a strain-specific match each year), slow manufacturing processing, vaccine strain egg-adapted changes, short duration of protection, lack of cross-reactivity, and poor immunogenicity in certain populations (e.g. the elderly). Antiviral agents such as neuraminidase inhibitors are most effective if administered early in the disease course, and even then, have only a modest impact upon the duration of clinical symptoms. Furthermore, data are inconclusive regarding the ability of neuraminidase inhibitors to reduce the risk of complications, such as hospitalizations or progression to pneumonia. Data are needed to better understand correlates of immune protection that could be afforded by influenza vaccination and to test new therapeutics. As such, influenza challenge models can be informative.
Human challenge models have several benefits to traditional models (e.g. animal models) that can advance scientific understanding of influenza infection, the efficacy of influenza vaccination, and the benefits of influenza therapy. Ultimately, discoveries from the influenza challenge model could decrease the morbidity and mortality associated with influenza. Animal models do not directly translate well in predicting baseline human influenza immunity and subsequent immunological responses. Human challenge studies have been successfully conducted historically and offer significant advantages. The human challenge model is efficient (relatively few subjects are required to power a study), immunological responses of humans can be studied directly, and the exact timing of infection is known so that specific time points and measurements are precisely determined, which is especially useful when testing new vaccinations or therapeutics. Human challenge studies for influenza are a particularly attractive modality for the development of a universal influenza vaccine. As outlined by the National Institute of Allergy and Infectious Diseases (NIAID) 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. 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 goal of this study is to conduct a human challenge study to validate the influenza challenge model at Emory University and better understand influenza pathogenesis, immunity, transmission and evolution. Up to forty healthy subjects will be challenged using a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2). Participants will take part in the study for 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 breathing in influenza virus through a device or in a tent followed by an inpatient stay for observation, or by being exposed to participants already infected with the flu virus followed by an inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center.
- Conditions
- Influenza
- Being tested
- Influenza Virus Type A H3N2 Challenge
- 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 Type A H3N2 ChallengeBiological
Also called A/Perth/16/2009 H3N2
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Influenza Virus Type A H3N2 Challenge |
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
The number of participants experiencing mild to moderate influenza disease (MMID) from challenge to discharge from quarantine.
Measured: Up to Day 8
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 Week 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 posted18 Apr 2022
- Study start24 May 2022
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332899
- Sponsor's protocol ID
- STUDY00000083
- Other IDs
- 2025P013079
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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.
Publications
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.
PubMed 39589151
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Human Challenge Model
- ClinicalTrials.gov ID
- NCT05332899
- Acronym / sponsor ID
- STUDY00000083
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Apr 2022 (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 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.
Detailed description
Influenza continues to cause a significant burden of disease globally and in the United States. In the United States alone, it's estimated that in the 2017-2018 season there were 959,000 hospitalizations related to influenza illness, and 79,400 deaths. Worldwide, the World Health Organization (WHO) estimates that annual influenza epidemics cause 3-5 million cases of severe disease, with 290,000-650,000 of these severe cases resulting in death. Although annual influenza immunizations are recommended and antivirals are available, both have several limitations. The efficacy of the seasonal influenza vaccine is compromised by several factors: antigenic changes over time (requiring a strain-specific match each year), slow manufacturing processing, vaccine strain egg-adapted changes, short duration of protection, lack of cross-reactivity, and poor immunogenicity in certain populations (e.g. the elderly). Antiviral agents such as neuraminidase inhibitors are most effective if administered early in the disease course, and even then, have only a modest impact upon the duration of clinical symptoms. Furthermore, data are inconclusive regarding the ability of neuraminidase inhibitors to reduce the risk of complications, such as hospitalizations or progression to pneumonia. Data are needed to better understand correlates of immune protection that could be afforded by influenza vaccination and to test new therapeutics. As such, influenza challenge models can be informative.
Human challenge models have several benefits to traditional models (e.g. animal models) that can advance scientific understanding of influenza infection, the efficacy of influenza vaccination, and the benefits of influenza therapy. Ultimately, discoveries from the influenza challenge model could decrease the morbidity and mortality associated with influenza. Animal models do not directly translate well in predicting baseline human influenza immunity and subsequent immunological responses. Human challenge studies have been successfully conducted historically and offer significant advantages. The human challenge model is efficient (relatively few subjects are required to power a study), immunological responses of humans can be studied directly, and the exact timing of infection is known so that specific time points and measurements are precisely determined, which is especially useful when testing new vaccinations or therapeutics. Human challenge studies for influenza are a particularly attractive modality for the development of a universal influenza vaccine. As outlined by the National Institute of Allergy and Infectious Diseases (NIAID) 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. 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 goal of this study is to conduct a human challenge study to validate the influenza challenge model at Emory University and better understand influenza pathogenesis, immunity, transmission and evolution. Up to forty healthy subjects will be challenged using a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2). Participants will take part in the study for 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 breathing in influenza virus through a device or in a tent followed by an inpatient stay for observation, or by being exposed to participants already infected with the flu virus followed by an inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza Challenge Model with Influenza A H3N2 Strain | Experimental | Biological: Influenza Virus Type A H3N2 ChallengeParticipants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (37 listed)
- Have household contact with or have daily contact with:
- 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.
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 Type A H3N2 ChallengeAlso: A/Perth/16/2009 H3N2The 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. | Biological | Influenza Challenge Model with Influenza A H3N2 Strain |
Primary outcome
Number of Participants with Mild to Moderate Influenza Disease
Time frame: Up to Day 8
The number of participants experiencing mild to moderate influenza disease (MMID) from challenge to 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 Week 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 27 Mar 2026.
- Derived from this study: PubMed 39589151Shetty 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be available for sharing including data on safety, participant demographics and immunogenicity.
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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 Type A H3N2 Challenge 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 16 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 27 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 8). 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?
On the ClinicalTrials.gov record for NCT05332899, which also lists 1 linked publication.
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 27 Mar 2026.