Rechallenge With a Low Pathogenicity Avian H10N7 Influenza Virus in Healthy Human Volunteers Previously Challenged With H10N7 Influenza

NCT07215871 | Enrolling By Invitation Phase 1 FDA Drug

• 2 other identifiers: 10002421002421-I
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections; Respiratory Tract Infections; Viral Diseases; Influenza Infection; Orthomyxoviridae Infections; Respiratory Virus Infections; RNA Viruses

Keywords

Influenza A; H10N7; Challenge Model; Influenza; Human Challenge

Outcome Measures

Primary Outcomes (1)

• Determine if participants develop mild-to-moderate influenza disease after a second challenge with H10N7.

  Subjects will remain inpatient for 9 days total to evaluate for infection and symptoms after infection with H10N7.

  9 days

Secondary Outcomes (2)

• 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.

  3 months

• Evaluate immune response after a second challenge with H10N7 compared to the initial challenge.

  2 years

Study Arms (1)

H10N7 Infection

EXPERIMENTAL

Subjects will be infected with H10N7 virus.

Biological: A/Mallard/Ohio-99/MM4/1989 H10N7

Interventions

A/Mallard/Ohio-99/MM4/1989 H10N7 BIOLOGICAL

Low pathogenicity avian influenza virus H10N7

H10N7 Infection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• An individual must meet all of the following criteria to be eligible for study participation:
• 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.
• 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 follow-up visit #2:
• Is infertile, including postmenopausal status (as defined by no menses for \>=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 90 days of inoculation (Day 0).

You may not qualify if:

• 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.
• 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 \>=65 years of age.
• Children \<=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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Choi YS, Baek YH, Kang W, Nam SJ, Lee J, You S, Chang DY, Youn JC, Choi YK, Shin EC. Reduced antibody responses to the pandemic (H1N1) 2009 vaccine after recent seasonal influenza vaccination. Clin Vaccine Immunol. 2011 Sep;18(9):1519-23. doi: 10.1128/CVI.05053-11. Epub 2011 Aug 3.

  PMID: 21813667 BACKGROUND

• Memoli MJ, Han A, Walters KA, Czajkowski L, Reed S, Athota R, Angela Rosas L, Cervantes-Medina A, Park JK, Morens DM, Kash JC, Taubenberger JK. Influenza A Reinfection in Sequential Human Challenge: Implications for Protective Immunity and "Universal" Vaccine Development. Clin Infect Dis. 2020 Feb 14;70(5):748-753. doi: 10.1093/cid/ciz281.

  PMID: 30953061 BACKGROUND

• Skowronski DM, Li Y, Tweed SA, Tam TW, Petric M, David ST, Marra F, Bastien N, Lee SW, Krajden M, Brunham RC. Protective measures and human antibody response during an avian influenza H7N3 outbreak in poultry in British Columbia, Canada. CMAJ. 2007 Jan 2;176(1):47-53. doi: 10.1503/cmaj.060204.

  PMID: 17200390 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Virus Diseases; Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; RNA Virus Infections

Study Officials

• Luca T Giurgea, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03-13

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)