CHIVIM studies for licensure
Develop consensus on best practices for using CHIVIM studies to support licensure of universal or broadly protective influenza vaccines.
Progress Highlights
Meln 2025 summarized outcomes from an Inno4Vac workshop held on March 20, 2024, to address the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity in CHIM studies, including influenza-related studies.
Cavaleri 2024 summarized discussions at the 4th Controlled Human Infection Model (CHIM) meeting on regulatory issues in CHIM studies, held on May 24, 2023; topics includedGMP production of challenge agents, ethics, community engagement, pre-existing immunity, and clinical, immunologic, and microbiologic endpoints.
Wellcome Trust 2023 identified how human infection study data can inform regulatory approval of new vaccines (e.g., by providing insights into disease mechanisms, host responses to infection, correlates of protection, optimal doses for phase 3 trials, and down-selecting vaccine candidates for clinical trials.)