Human Infection Study of H3N2 Influenza in Healthy Adults (NCT06972810) | Clinical Trial Compass
CompletedNot Applicable
Human Infection Study of H3N2 Influenza in Healthy Adults
Australia11 participantsStarted 2025-05-05
Plain-language summary
This study will examine how the immune system responds to a flu virus (H3N2) during and after infection in health adults aged between 18 and 50 while in an inpatient facility.
The study uses a specific flu virus called the H3N2 influenza challenge virus, that was produced specifically for use in clinical research in controlled conditions. From a previous study, mild to moderate symptoms are expected.
This is the first time that a flu challenge study has been undertaken in Australia.
Who can participate
Age range
18 Years – 50 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
. General good health, without significant medical conditions that would interfere with participant safety, as defined by medical history, physical examination, screening laboratory tests, and ECG at a screening evaluation.
. Susceptible to the challenge virus as determined by a baseline serum HAI and NAI antibody titer to the RG-A/Texas/71/2017 (H3N2; clade 3c3a) virus of 1:40 or less.
. Able to understand and comply with planned study procedures and available for the duration of the trial.
. Willing to participate in the study and adhere to all trial requirements, including providing written consent to remain at the trial site for at least seven days after administration of the challenge virus. This willingness must be demonstrated by signing the informed consent document.
. Willing to allow the investigators to discuss the participant's medical history with their General Practitioner or any relevant health professional.
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
Percentage of participants who become infected with the virus
. Willing to refrain from donating blood for the duration of the study period.
. Willing to refrain from smoking and illicit drug use during the quarantine period.
. Women of childbearing potential (WOCBP)\* are required to practice a highly effective form of contraception during the course of the study. Acceptable forms of contraception for female participants include:
Exclusion criteria
. History of clinically significant or currently active neurological, cardiac, respiratory, hepatic, rheumatological, autoimmune, or renal disease. Specifically:
. History of chronic obstructive pulmonary disease, pulmonary hypertension, or chronic lung condition of any etiology;
. Current diagnosis of asthma or reactive airway disease (e.g., to viral infections) within the past 2 years;
. History of thromboembolic, cardiovascular or cerebrovascular disease;
. Current diabetes mellitus (Type I or Type II);
. Any history of malignancy except for non-recurrent basal cell carcinoma;
. History or evidence of clinically significant autoimmune disease or known immunodeficiency of any cause (including HIV);