Study of pH1N1 Influenza Virus Challenge
This study is testing a specific influenza A virus, A/Arkansas/08/2020 (pH1N1), to find the best dose for future research on flu treatments. You might receive this virus or a sham (inactive) liquid called Sham/Diluent (1X SPG+Arg+Gel). Researchers will look at how many participants have serious side effects, any side effects, and if they develop flu symptoms. This study is for adults aged 18 to 55. To join, you must be healthy and have low levels of a specific antibody (serological HAI antibody titers of <=1:40) against the flu strain being studied. The study aims to enroll about 90 participants who receive the virus and 6 who receive the sham. The current recruitment status is unclear.
- Study design
- This is an interventional study that will involve challenging adult volunteers with either the pH1N1 influenza virus or a sham inoculation. It is a blinded study, meaning you won't know if you're receiving the virus or the sham.
- What's involved
- You will need to provide signed consent and be available for all study visits. Participants will be pre-screened for health and specific antibody levels before enrollment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track serious side effects from the first inoculation through Day 57, and any side effects through Day 29. They will also monitor for symptomatic influenza virus infection from Day 2 through Day 6.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07110532
pH1N1 Blinded Challenge Study
Recruiting
PHASE1Ages 18–55InterventionalNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~90 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:A/Arkansas/08/2020 (pH1N1)Sham/Diluent (1X SPG+Arg+Gel)
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants reporting a related SAE at any time from the time of the first challenge inoculation.
Measured over Through Day 57
+4 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesMaryland1
North Carolina1
Who to contact
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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
Inclusion
White blood cell (WBC), Absolute lymphocyte count (ALC), Hemoglobin (Hgb), Platelet (PLT). Lab tests within normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
Alanine transferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase, Alkaline Phosphatase (ALP), Total Bilirubin, and Creatinine (Cr). Low values are acceptable for trial inclusion as they are not considered to be clinically significant. 20. Has a negative test result for hepatitis B surface antigen, hepatitis C virus antibody\*, or HIV types 1 or 2 antibodies at screening.
Exclusion
Any condition that, in the opinion of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, might interfere with the safety of the participant and/or study objectives including, but not limited to the following:
Respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\], asthma) requiring daily medications (Inhaled, oral, or intravenous corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics) or any treatment for respiratory disease exacerbations (e.g., asthma exacerbation) within the last 5 years
Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult
Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, encephalopathy, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis). A history of febrile seizures during childhood alone is not diagnostic of epilepsy.
Anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration
Significant abnormality altering anatomy of nose/nasopharynx (including significant nasal polyps), clinically significant nasal deviation, nasal/sinus surgery within 180 days prior to enrollment, spontaneous epistaxis requiring medical care within 180 days prior to enrollment, chronic or recurrent sinusitis (four or more distinct episodes of sinusitis, with symptom-free intervals between episodes) in the last year prior to enrollment
Significant immunodeficiency
Known infection by human immunodeficiency virus (HIV) or hepatitis B virus, or known untreated hepatitis C virus infection
Ongoing malignancy or diagnosis of malignancy in the last five years (excluding squamous cell or basal cell carcinoma of the skin)
Diabetes
Blood dyscrasias or significant disorder of coagulation 2. HAI antibody titer \>1:40 against influenza A/Arkansas/08/2020 (pH1N1) at screening 3. Current or within 4-month use of medications that may be associated with impaired immune responsiveness\* \*Including, but not limited to, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (i.e., exceeding 14 days of use and/or exceeding 10 mg/ day prednisone equivalent) or other similar or toxic drugs during the preceding 3-month period prior to screening. Low dose systemic corticosteroids (10mg/day or lower of prednisone) for 14 days or fewer are permitted. Low dose topical and intranasal steroid preparations are allowed, if not within 7 days of challenge or during the confinement period. 4. Current pregnancy\* or lactation
What this trial measures
- Number and percentage of participants reporting a related SAE at any time from the time of the first challenge inoculation.Through Day 57
- Number and percentage of participants reporting any related AE from the time of the first challenge inoculation.Through Day 29
- Number and percentage of participants with symptomatic influenza virus infection.Day 2 through Day 6
"Symptomatic influenza virus infection" is defined as meeting both of these criteria: 1. Viral shedding detected in NP swab specimens by qualitative RT-PCR; and 2. A cumulative symptom score \>/=6 using a Modified Jackson Score.
- Number of related adverse events (AE) reported from the time of the first challenge inoculation.Through Day 29
- Number of related serious adverse events (SAE) from the time of the first challenge inoculation.Through Day 57