University of Minnesota
https://twin-cities.umn.edu/
612-625-5000
Milestone
5.2.a

Guidance for use

Completed
High priority

Generate guidance, including ethical and safety considerations, for using the CHIVIM.

Progress Highlights

Lane 2024 summarized the presentations, discussions, key takeaways, and future directions for innovations in CHIVIMs from a workshop (CHIVIM studies: current status and future directions for innovation, Nov. 13-14, 2023) convened by NIAID on use cases and regulatory and ethical considerations for CHIVIM studies; participants included industry, academic, and government researchers. This meeting was a follow-up to the 2018 meeting in London on the influenza human challenge model for universal influenza vaccine development (Innis 2019).

See summary
 

UK Pandemic Ethics Accelerator 2023 provides guidance on when it may be appropriate to conduct controlled human infection model studies and on the requirements for their ethical conduct.

See guidance


Dayananda 2022 reviews the use of human challenge models in RSV vaccine R&D, including ethical and logistical considerations, potential benefits, their role in streamlining and accelerating novel vaccines, and potential extension to include relevant at-risk populations.

See research
 

Williams 2022 reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies.

See research


WHO 2022 provides global guidance on the ethical conduct of controlled human infection studies, which includes language on influenza. 

See guidance


HIC-Vac (UK) provides information and expertise regarding the use of human infection challenge studies for vaccine R&D particularly in the UK and LMICs. 

See network website

Lane 2024 summarized the presentations, discussions, key takeaways, and future directions for innovations in CHIVIMs from a workshop (CHIVIM studies: current status and future directions for innovation, Nov. 13-14, 2023) convened by NIAID on use cases and regulatory and ethical considerations for CHIVIM studies; participants included industry, academic, and government researchers. This meeting was a follow-up to the 2018 meeting in London on the influenza human challenge model for universal influenza vaccine development (Innis 2019).

See summary
 

Wellcome Trust 2023 summarizes outcomes of an international multi-stakeholder meeting on how human infection study data can inform regulatory approval of new vaccines.

See summary
 

Abo 2023 reviewed vaccine development following trials in human challenge models, highlighting the potential for human challenge trials to accelerate development of vaccines against priority pathogens and in pandemic and non-pandemic settings.

See research