NCT07215871
Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Previously Challenged With H10N7 Influenza
Enrolling by Invitation
PHASE1Ages 18–55InterventionalBasic scienceNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~33 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:A/Mallard/Ohio-99/MM4/1989 H10N7
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine if participants develop mild-to-moderate influenza disease after a second challenge with H10N7.
Measured over 9 days
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Luca T Giurgea, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
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. 3. Has a body mass index (BMI) \<=18.5 or \>=35. 4. 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. 5. History of facial reconstructive procedures or nasopharyngeal malformation that would preclude nasal sampling. 6. Positive for hepatitis B or hepatitis C infections. 7. 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. 8. Grade 2 or higher hemoglobin decrease for female participants or Grade 1 or higher hemoglobin decrease for male participants. 9. 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. 10. Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI. 11. Clinically significant abnormality as deemed by the PI on ECG. 12. Clinically significant abnormality as deemed by the PI on ECHO. 13. Clinically significant abnormality as deemed by the PI on the PFT and/or spirometry. 14. Recent acute illness within 1 week of admission to the NIH CC. 15. Positive test for any respiratory virus on nasal wash (including but not limited to SARSCoV-2) on admission. 16. Known allergy to any component of the interventional agent. 17. Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals anti-inflammatory drugs). 18. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides). 19. Receipt of influenza vaccine within 8 weeks prior to enrollment. 20. Receipt of a broadly protective influenza vaccine or avian influenza vaccine. 21. Natural infection with avian influenza outside of the research setting. 22. Having influenza infection within 8 weeks prior to enrollment. 23. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment. 24. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment. 25. Receipt of any unlicensed vaccine within 6 months prior to enrollment. 26. 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 metabolite and tetrahydrocannabinol or metabolites). 27. Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation. 28. Known close contact with anyone known to have influenza in the past 7 days. 29. Known close contact with anyone known to have COVID-19 in the past 14 days. 30. History of COVID-19-related complications, including, but not limited to: inpatient hospitalization, required the use of oxygen, and/or on-going sequelae. 31. 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.
What this trial measures
- Determine if participants develop mild-to-moderate influenza disease after a second challenge with H10N7.9 days
Subjects will remain inpatient for 9 days total to evaluate for infection and symptoms after infection with H10N7.