Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Prev… (NCT07215871) | Clinical Trial Compass
By InvitationPhase 1
Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Previously Challenged With H10N7 Influenza
United States33 participantsStarted 2026-04-21
Plain-language summary
Background:
Influenza (flu) is a virus that can infect humans and animals. In humans, the flu can cause mild symptoms such as fever, cough, sore throat, runny nose, muscle aches, headaches, and fatigue. It can also cause sinus infections or pneumonia. Some flu strains, such as H5N1 and H7N9, which come from birds, can lead to more severe symptoms or death. Others, like H10N7, also come from birds but usually cause mild symptoms. Researchers want to study bird flu in humans to help develop new flu vaccines and treatments.
Objective:
To learn more about how bird flu viruses infect humans.
Eligibility:
Healthy people aged 18 to 55 years who were infected with the H10N7 bird flu strain as part of a previous study.
Design:
Participants who were infected with H10N7 in a previous study will be infected again with the same virus. The virus will be sprayed into their nostrils.
Participants will stay in the hospital for at least 9 days. They will stay in an isolation unit. No outside visitors will be allowed.
During their stay, participants will provide blood, urine, and nasal fluid samples. They will have tests of their heart and lung function. They will complete questionnaires about their symptoms.
Participants will remain in the hospital until they test negative for the flu 2 days in a row. They will continue to complete questionnaires about their symptoms for 2 weeks after they were infected with the virus.
Participants will have 2 follow-up visits, at 5 weeks and 9 weeks after they were infected. They will have a physical exam and provide samples of blood and nasal fluids. They will have a test of their heart function.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Previously participated in the H10N7 influenza challenge study 20-I-0160 ("Dose- Escalation Study of a Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model") and given a viral challenge H10N7.
✓. \>=18 and \<=55 years of age.
✓. Able to provide informed consent.
✓. Agrees to not use tobacco products, marijuana, or vaping products through the last mandatory visit.
✓. Willing to remain in isolation for a minimum of 9 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 follow-up visit #2:
✓. Is infertile, including history of successful vasectomy.
✓. Agrees to practice abstinence.
Exclusion criteria
✕
What they're measuring
1
Determine if participants develop mild-to-moderate influenza disease after a second challenge with H10N7.
Timeframe: 9 days
Trial details
NCT IDNCT07215871
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).