Open-label, phase 1/2, dose-escalation and dose-confirmation clinical trial to establish a Controlled Human Infection Model (CHIM) by determining and confirming the optimal, safe, and reproducible Influenza A:H3N2 dose administered intranasally to healthy adults 18-40 years of age that induces mild symptomatic infection and detection of Influenza A:H3N2 in nasal secretions by culture and/or PCR

  • Funded by Canadian Institutes of Health Research (CIHR)
  • Total publications:0 publications

Grant number: 497367

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Key facts

  • Disease

    Influenza caused by Influenza A virus subtype H3
  • start year

    2023
  • Known Financial Commitments (USD)

    $3,305,233.25
  • Funder

    Canadian Institutes of Health Research (CIHR)
  • Principal Investigator

    Halperin Scott A, Ward Brian J
  • Research Location

    Canada
  • Lead Research Institution

    Dalhousie University (Nova Scotia)
  • Research Priority Alignment

    N/A
  • Research Category

    Vaccines research, development and implementation

  • Research Subcategory

    Phase 1 clinical trial

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase I

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

This clinical trial is designed to establish a Controlled Human Infection Models (CHIM) for influenza A virus. In a CHIM, a pathogen of interest (such as a virus) is safely given to healthy volunteers 18 to 40 years of age under closely controlled conditions in an inpatient isolation facility in order to safely study the immune response to the infection and to test the safety and efficacy of new vaccines to prevent and antivirals to treat the infection. CHIMs are an efficient way to assess whether new vaccines and treatments are safe and if they work and can accelerate the approval process when there is a public health emergency like a pandemic. In this study, we will give gradually increasing amounts of virus to small groups of volunteers until we find the dose that infects 70-90% of the group and produces mild influenza-like symptoms. Once mild symptoms occur in any participant, they will be treated with an antiviral to clear the virus from their body.The methodology developed by this study can be adapted for establishing CHIMs for other pathogens of pandemic potential. This CHIM for pathogens of pandemic potential can become an important part in Canada's pandemic preparedness armamentarium and accelerate the expeditious translation of Canadian innovative technology to commercialization and market readiness.