Influenza InfectionPhase 1NCT05436444
Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model
A Phase 1 study testing A/Mallard/Ohio-99/MM4/1989 H10N7 in people with Influenza Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Influenza Infection
- What is being tested?
- A/Mallard/Ohio-99/MM4/1989 H10N7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 17 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- An individual must meet all of the following criteria to be eligible for study participation:
- Greater than or equal to 18 and less than or equal to 50 years of age.
- Able to provide consent.
- Agrees to not use tobacco products, marijuana, or vaping products during participation in this study.
- Willing to remain in isolation for a minimum of 10 calendar days (or for the duration of viral shedding) and to comply with all study requirements.
- A male subject is eligible for the study if he meets one of the following criteria, beginning at least 4 weeks prior to enrollment and continuing until 10 weeks after administration of the human challenge virus and follow-up visit #4:
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- Is infertile, including history of successful vasectomy.
- Agrees to practice abstinence.
- Agrees that, with heterosexual intercourse with a fertile female partner, he will use a condom with spermicide and his female partner (including those who have undergone bilateral tubal ligation) will use an acceptable form of contraception (see inclusion criterion 6c).
- A female participant is eligible for this study if she is not pregnant or breastfeeding and meets one of the following criteria, beginning at least 4 weeks prior to enrollment and continuing until 10 weeks after administration of the human challenge virus and follow-up visit #4:
- Is infertile, including postmenopausal status (as defined by no menses for greater than or equal to 1 year) or history of hysterectomy.
- Agrees to practice abstinence.
- Agrees that, with heterosexual intercourse with a fertile male partner, she will use an acceptable form of contraception and her male partner will use a condom with spermicide. Acceptable effective methods of female contraception include the following: bilateral tubal ligation, implant of levonorgestrel, injectable progestogen, intrauterine device, oral contraceptive pills, and diaphragm with spermicide.
- Willing to have samples stored for future research.
- Human immunodeficiency virus (HIV) uninfected with a negative test within 60 days of inoculation (Day 0).
Who cannot join
- An individual meeting any of the following criteria will be excluded from study participation:
- Has self-reported or medically documented significant medical condition including but not limited to:
- Chronic pulmonary disease (e.g., asthma, 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., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or ongoing malignancy.
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- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Post-infectious or post-vaccine neurological sequelae.
- Has close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Persons greater than or equal to 65 years of age.
- Children less than or equal to 5 years of age.
- Residents of nursing homes.
- Persons of any age with significant chronic medical conditions such as:
- Chronic pulmonary disease (e.g., asthma).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Chronic medical conditions requiring medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or cancer.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Persons who are receiving long-term aspirin therapy.
- Women who are pregnant, trying to become pregnant, or breastfeeding.
- Has a body mass index (BMI) less than or equal to 18.5 or greater than or equal to 35.
- Smokes more than 4 cigarettes or other tobacco products on a weekly basis or any type of vaping/e-cigarette use more than 4 times per week.
- History of facial reconstructive procedures or nasopharyngeal malformation.
- Positive for Hepatitis B or Hepatitis C infections.
- Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (DLM) normal reference range and deemed clinically significant by the PI.
- Grade 2 or higher Hemoglobin for female participants or Grade 1 or higher Hemoglobin for male participants.
- Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase (LDH), uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
- Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
- Clinically significant abnormality as deemed by the PI on ECG.
- Clinically significant abnormality as deemed by the PI on ECHO.
- Clinically significant abnormality as deemed by the PI on the PFT and/or spirometry.
- Recent acute illness within 1 week of admission to the NIH CC.
- Known allergy to any component of the interventional agent.
- Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals).
- Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
- Receipt of influenza vaccine within 8 weeks prior to enrollment.
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
- Receipt of any unlicensed vaccine within 6 months prior to enrollment.
- Self-reported or known history of current alcoholism or drug abuse, or positive urine/serum test for drugs of abuse (i.e., amphetamines, cocaine, benzodiazepines, opiates, or metabolites, but not tetrahydrocannabinol or metabolites).
- Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation
- Known close contact with anyone known to have influenza in the past 7 days.
- Known close contact with anyone known to have COVID-19 in the past 14 days.
- History of COVID-19-related complications, including, but not limited to: inpatient hospitalization, required the use of oxygen, and/or on-going sequelae.
- Non-English speaking participants.
- Any condition that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Dose-Escalation Study of a Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model
Background:
Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu.
Read more
Objective:
To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work.
Eligibility:
Healthy adults age 18-50.
Design:
Participants will be screened with:
Physical exam with vital signs and weight
Medical and medicine review
Blood and urine tests
Electrocardiogram to measure the heart s electrical activity.
Screening tests will be repeated during the study.
Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose.
Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors.
Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity.
One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms.
Participants will be discharged after they have 2 consecutive negative tests for flu.
Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks.
Read the detailed description
Study Description:
This is a dose-finding and pathogenicity study following human challenge with a low pathogenicity avian influenza A H10N7. Participants will be inoculated with 1 dose of challenge virus during the study and then followed for a minimum of 9 weeks after inoculation. Progressively increasing doses will be used according to a specific plan until either the maximum dose is reached or at least 60% of participants develop mild to moderate influenza disease (MMID).
Objectives:
Primary Objective:
- Determine the safe dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers or identify the rate of MMID at the maximum dose of 10^7 50% Tissue Culture Infective Dose (TCID50).
Secondary Objective:
- Evaluate clinical disease, identify clinical markers, and observe initiation of shedding, length of shedding, and pathogenesis in participants with low pathogenicity avian influenza A infection.
Exploratory Objective:
- Discover viral factors necessary for human infection/adaptation and evaluate host immune response, viral replication, viral fitness, and intrahost evolution.
Endpoints:
Primary Endpoint:
- Rate of MMID, defined as a positive US Food and Drug Administration (FDA) approved clinical test for influenza plus one or more influenza symptoms.
Secondary Endpoints:
- Daily and total score on FLU-PRO questionnaire in each participant
- Number and duration of symptoms and signs elicited by daily oral history and clinical exam
- Duration and quantity of shedding of influenza in nasal wash/SAM by quantitative real-time polymerase chain reaction (rtPCR).
Exploratory Endpoints:
- Levels and type of influenza infection induced gene expression determined by human gene expression analysis and high-throughput sequencing.
- Levels of mucosal and systemic antibodies after inoculation.
- Change in viral genotype from the inoculum of virus isolated from infected participants.
- Conditions
- Influenza Infection
- Being tested
- A/Mallard/Ohio-99/MM4/1989 H10N7
- Keywords
- Influenza A, H10N7, Challenge Model, Influenza, Human 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.
A/Mallard/Ohio-99/MM4/1989 H10N7Biological
The human challenge virus will be administered intranasally to each participant using a nasal atomizer. A total volume of up to 2 mL will be administered split between both nostrils of each participant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All participants receive challenge virus Receives: Biological: A/Mallard/Ohio-99/MM4/1989 H10N7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced.
To determine the dose of A /Mallard/Ohio-99/MM4/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers.
Measured: 9 days
Secondary outcomes (1)
Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam
To evaluate clinical disease, identify clinical markers, and observe initiation of shedding, length of shedding, and pathogenesis in participants
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start23 Oct 2023
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Influenza InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436444
- Sponsor's protocol ID
- 200160
- Other IDs
- 20-I-0160
- Status last verified
- 20 Feb 2025
- First submitted
- 17 Jun 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are not working with any outside collaborators that require this information.
Publications
Beare AS, Webster RG. Replication of avian influenza viruses in humans. Arch Virol. 1991;119(1-2):37-42. doi: 10.1007/BF01314321.
PubMed 1863223Memoli MJ, Czajkowski L, Reed S, Athota R, Bristol T, Proudfoot K, Fargis S, Stein M, Dunfee RL, Shaw PA, Davey RT, Taubenberger JK. Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. Clin Infect Dis. 2015 Mar 1;60(5):693-702. doi: 10.1093/cid/ciu924. Epub 2014 Nov 20.
PubMed 25416753KASEL JA, ALFORD RH, KNIGHT V, WADDELL GH, SIGEL MM. EXPERIMENTAL INFECTION OF HUMAN VOLUNTEERS WITH EQUINE INFLUENZA VIRUS. Nature. 1965 Apr 3;206:41-3. doi: 10.1038/206041a0. No abstract available.
PubMed 14334358
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalation Study of a Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model
- ClinicalTrials.gov ID
- NCT05436444
- Acronym / sponsor ID
- 200160
- Conditions
- Influenza Infection
- Keywords
- Influenza A, H10N7, Challenge Model, Influenza, Human Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 29 Jun 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.
Background:
Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu.
Objective:
To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work.
Eligibility:
Healthy adults age 18-50.
Design:
Participants will be screened with:
Physical exam with vital signs and weight
Medical and medicine review
Blood and urine tests
Electrocardiogram to measure the heart s electrical activity.
Screening tests will be repeated during the study.
Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose.
Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors.
Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity.
One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms.
Participants will be discharged after they have 2 consecutive negative tests for flu.
Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks.
Detailed description
Study Description:
This is a dose-finding and pathogenicity study following human challenge with a low pathogenicity avian influenza A H10N7. Participants will be inoculated with 1 dose of challenge virus during the study and then followed for a minimum of 9 weeks after inoculation. Progressively increasing doses will be used according to a specific plan until either the maximum dose is reached or at least 60% of participants develop mild to moderate influenza disease (MMID).
Objectives:
Primary Objective:
- Determine the safe dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers or identify the rate of MMID at the maximum dose of 10^7 50% Tissue Culture Infective Dose (TCID50).
Secondary Objective:
- Evaluate clinical disease, identify clinical markers, and observe initiation of shedding, length of shedding, and pathogenesis in participants with low pathogenicity avian influenza A infection.
Exploratory Objective:
- Discover viral factors necessary for human infection/adaptation and evaluate host immune response, viral replication, viral fitness, and intrahost evolution.
Endpoints:
Primary Endpoint:
- Rate of MMID, defined as a positive US Food and Drug Administration (FDA) approved clinical test for influenza plus one or more influenza symptoms.
Secondary Endpoints:
- Daily and total score on FLU-PRO questionnaire in each participant
- Number and duration of symptoms and signs elicited by daily oral history and clinical exam
- Duration and quantity of shedding of influenza in nasal wash/SAM by quantitative real-time polymerase chain reaction (rtPCR).
Exploratory Endpoints:
- Levels and type of influenza infection induced gene expression determined by human gene expression analysis and high-throughput sequencing.
- Levels of mucosal and systemic antibodies after inoculation.
- Change in viral genotype from the inoculum of virus isolated from infected participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: A/Mallard/Ohio-99/MM4/1989 H10N7All participants receive challenge virus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- An individual must meet all of the following criteria to be eligible for study participation:
- Greater than or equal to 18 and less than or equal to 50 years of age.
- Able to provide consent.
- Agrees to not use tobacco products, marijuana, or vaping products during participation in this study.
- Willing to remain in isolation for a minimum of 10 calendar days (or for the duration of viral shedding) and to comply with all study requirements.
Key exclusion criteria (46 listed)
- An individual meeting any of the following criteria will be excluded from study participation:
- Has self-reported or medically documented significant medical condition including but not limited to:
- Has close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Has a body mass index (BMI) less than or equal to 18.5 or greater than or equal to 35.
- Smokes more than 4 cigarettes or other tobacco products on a weekly basis or any type of vaping/e-cigarette use more than 4 times per week.
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 |
|---|---|---|
| A/Mallard/Ohio-99/MM4/1989 H10N7The human challenge virus will be administered intranasally to each participant using a nasal atomizer. A total volume of up to 2 mL will be administered split between both nostrils of each participant. | Biological | 1 |
Primary outcome
The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced.
Time frame: 9 days
To determine the dose of A /Mallard/Ohio-99/MM4/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers.
1 secondary outcome
Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 1863223Beare AS, Webster RG. Replication of avian influenza viruses in humans. Arch Virol. 1991;119(1-2):37-42. doi: 10.1007/BF01314321.
- Background: PubMed 25416753Memoli MJ, Czajkowski L, Reed S, Athota R, Bristol T, Proudfoot K, Fargis S, Stein M, Dunfee RL, Shaw PA, Davey RT, Taubenberger JK. Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. Clin Infect Dis. 2015 Mar 1;60(5):693-702. doi: 10.1093/cid/ciu924. Epub 2014 Nov 20.
- Background: PubMed 14334358KASEL JA, ALFORD RH, KNIGHT V, WADDELL GH, SIGEL MM. EXPERIMENTAL INFECTION OF HUMAN VOLUNTEERS WITH EQUINE INFLUENZA VIRUS. Nature. 1965 Apr 3;206:41-3. doi: 10.1038/206041a0. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are not working with any outside collaborators that require this information.
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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. This study is not recruiting at the moment.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A/Mallard/Ohio-99/MM4/1989 H10N7 in people with Influenza Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 15 inclusion and 46 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: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced. (time frame: 9 days). 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 NCT05436444, which also lists 3 linked publications.
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 11 Mar 2025.