About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Hypertension, angina, or prior myocardial infarction
Trial design
Treatments tested in this trial
- Intranasal inoculation of RG-A/Texas/71/2017 (H3N2) influenza in each naris on Day 1 of the study.
Treatment groups
Locations
Sponsors and collaborators
Dalhousie University
Lead sponsor
Canadian Center for Vaccinology
Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator