Pilot Influenza Challenge Study (NCT07063849) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pilot Influenza Challenge Study
United States12 participantsStarted 2025-05-20
Plain-language summary
This is a research study to understand what happens when a person is infected with influenza ("flu") and how the body controls the infection. Healthy participants (challenge) will be infected with a strain of flu (H3N2), and followed to see what symptoms occur and when they occur. Blood will be drawn and nasopharyngeal (NP) swabs will be collected before participants are infected to understand if having antibodies can protect participants from flu infection or lead to a milder flu illness. Blood will also be drawn and NP swabs collected after participants are infected to understand how and when the body's immune response to flu occurs. Participants will also breathe through a device for virus collection every other day.
Participants will be screened during one or more visits and will stay in the inpatient challenge unit for at least 10 days, maybe longer. Participants will complete a FLU PRO Diary Card daily. Blood will be drawn before the challenge and on Days 2, 4, and 8 while in the inpatient unit. NP samples will be taken every day to check for viruses and on certain days, immune responses such as antibodies. If on Day 8 (7 days after the challenge) the participant still has flu virus, medicine will be offered to treat the flu and the participant will be asked to stay in the challenge unit until NP swabs are negative for 2 consecutive days. Once the participant is discharged from the challenge unit, they will be asked to return to the clinic for 3 more visits. At the end of the study will be a final phone call.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent prior to initiation of any study procedure.
. Are able to understand and comply with planned study procedures and be available for all study visits.
. Agree to remain an inpatient for at least seven days after challenge, AND until they have no virus shedding,1 determined by qualitative RT-PCR for a minimum of two consecutive days post-challenge 1For a minimum of seven days post-challenge (Study Day 8).
. Healthy2 males and non-pregnant, non-breastfeeding females3 aged ≥18 and ≤45 years of age, inclusive, at enrollment.
Exclusion criteria
. Female subject who has a positive pregnancy test on screening or admission, is breastfeeding or planning to become pregnant from 30 days prior to challenge through the end of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAE) during inpatient challenge
Timeframe: Post-challenge Day 1 through Day 8
2
Frequency of AE and SAE post-inpatient discharge
Timeframe: Thoughout the duration of the study (approximately three months post challenge)
3
FLU-PRO symptomatic scoring of clinical symptoms twice daily
Timeframe: Day 2 through at least Day 8 after challenge
4
H3N2-specific polymerase chain reaction (PCR) on nasopharyngeal (NP) samples daily
Timeframe: Day 2 through at least Day 8 post-challenge
5
H3N2 viral loads as assessed by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Timeframe: Days 2, 4, 6, and 8 post challenge
6
H3N2 viral clonotypic complexity by Next-Gen sequencing of NP and exhaled breath samples.
. Presence of self-reported or medically documented significant medical or psychiatric condition(s)15 15Significant medical or psychiatric conditions include but are not limited to:
. Respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\], asthma) requiring daily medications15 currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years 16Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
. Presence of any febrile illness or symptoms suggestive of a respiratory infection within two weeks prior to CHI.
. 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, seizures, encephalopathy, focal neurologic deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis).
. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell carcinoma of the skin, which is allowed.
. An autoimmune disease.
Studies of biologically relevant mutations in the H3N2 viral genome post-challenge discovered by Next-Gen sequencing of NP and exhaled breath samples
Timeframe: Days 2, 4, 6, and 8 post challenge
8
Relative abundance of live H3N2 virus shed in exhaled breath within droplets (diameter greater than or equal to 5 microns) and aerosols (diameter less than 5 microns)
Timeframe: Days 2, 4, 6, and 8 post challenge
9
H3N2 viral loads as assessed by median tissue culture infective dose (TCID50) assays