Not Yet RecruitingPhase 1

Establishing a Controlled Human Infection Model for Influenza H3N2 as a Foundation for Pandemic Preparedness

32 participantsStarted 2026-02-01

Plain-language summary

The overall objective is to establish an influenza Controlled Human Infection Model (CHIM) in Canada that can be used to assess the safety and efficacy of candidate vaccines, biologics, and therapeutics targeting influenza viruses.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained from the participant.
✓. 18-45 years of age.
✓. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge date.
✓. HAI antibody titer ≤1:40 against influenza A/Texas/71/2017 (H3N2).
✓. Eligibility laboratory values\* (complete blood cell count with differential (CBC-D), biochemistry (creatinine (Cr), total bilirubin, blood urea nitrogen (BUN), aspartame aminotransferase (AST), alanine transaminase (ALT), and c-reactive protein (CRP))\*Labs within normal range or grade 1 abnormalities deemed not clinically significant by a study investigator are considered acceptable.
✓. Vital signs\*\* as follows:
✓. Pulse is 47 to 99 beats per minute
✓. Systolic blood pressure is 85 to 139 mmHg

Exclusion criteria

✕. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
✕. Underlying renal disease or disorders requiring ongoing follow-up and monitoring by a physician. In the event a participant has a minimally elevated BUN and/or Cr at screening, the participant will either be excluded or an eCRF or creatinine clearance may be conducted to determine eligibility.
✕. Underlying coagulation disorder history. In the event a participant reports a personal history of undiagnosed prolonged bleeding and/or recurrent nosebleeds or a personal or family history of coagulation disorders, a bleeding panel (PTT, INR, fibrinogen) will be used to rule out coagulopathy.
✕. Underlying cardiac conditions including:
✕. Hypertension, angina, or prior myocardial infarction
✕. Structural or functional cardiac disease (e.g., dilated cardiomyopathy, congestive heart failure)
✕. With a history of arrhythmias/dysrhythmias (e.g., torsades de pointes, atrial fibrillation)
✕. Cardiac conduction abnormalities (e.g., congenital or acquired heart block)

What they're measuring

Symptomatic influenza-virus infection

Timeframe: Study Day 2 until Study Day 8

Trial details

NCT IDNCT07305207

SponsorDalhousie University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Nick Bartlett

902-470-8141 nicholas.bartlett@iwk.nshealth.ca

View on ClinicalTrials.gov More Influenza (Healthy Volunteers) trials