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 range18 Years – 50 Years
SexALL
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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.
✓. 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:
What they're measuring
1
Percentage of participants who become infected with the virus