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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDalhousie University

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

32 Participants
are divided into 3 treatment groups

Locations

This trial has no 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