“Refining the Regulatory Context of CHIMS:” Workshop held in The Netherlands
- danielreem
- 14 minutes ago
- 2 min read
November 2025
On 17 October, Inno4Vac project hosted a successful workshop at the LUMC campus in Leiden, centred around regulatory and ethical considerations regarding Controlled Human Infection Models, or CHIMs.
The full-day event was organised by the International Alliance for Biological Standardization (IABS-EU), and brought together 60 leading researchers, industry experts, regulators, and ethicists in an effort to:
Refine frameworks around CHIM-related regulatory and practical issues.
Explore the potential use of CHIMs (RSV, C. difficile, influenza) in accelerating vaccine development.
Discuss ethical, regulatory, and scientific challenges, such as GMP alignment, bystander safety, and community engagement
The morning agenda included presentations of CHIMs developed within Inno4Vac for C. difficile and RSV, illustrating their development, challenges encountered, and initial results. A keynote lecture was given by Anna Durbin (Johns Hopkins Bloomberg School of Public Health) titled “To use a CHIM, yes or no?”, and an industry perspective on the role of CHIMs within the product development pipeline was also given by representatives of GSK and Sanofi.
The afternoon sessions were dedicated to the ethics surrounding the concept of CHIMs, with input given from representatives of the Central Committee on Research Involving Human Subjects and Lurie Children’s Hospital of Chicago, and a panel discussion to end the day.
Overall, the workshop facilitated interesting exchanges on the ethics of CHIM and the impact of CHIM on the regulatory process.
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Contact:
Dr. Nicola Viebig (Director of Research at the European Vaccine Initiative)
Email: nicola.viebig@euvaccine.eu
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799 (Inno4Vac). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (www.imi.europa.eu). This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.
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