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New scientific article from Inno4Vac workshop on ‘design of Controlled Human Infection Models’

This report summarizes expert consensus reached during discussions regarding design and ethical considerations of Controlled Human Infection Model (CHIM) research and demonstrates Inno4Vac’s ongoing commitment to the field.

January 2025


The EVI-led project Inno4Vac, aims to develop advanced and safe CHIMs that can improve and accelerate vaccine development. CHIMs are clinical studies that can be used for accelerating testing and derisking of potential new vaccines and drugs in a controlled clinical environment, through knowledge gleaned from studying the pathophysiology of infectious diseases. CHIMs are an integral part of the Inno4Vac workplan.

Today, we are pleased to announce the publication of a new scientific article from Inno4Vac(*), resulting from a 20 March 2024 workshop jointly organised by EVI and the Centre for Human Drug Research (CHDR).

Held at CHDR in Leiden, The Netherlands, the workshop connected experts in clinical trial design, ethics and patient advocacy to discuss standardisation of clinical procedures, endpoints, and data integrity of the CHIMs within the Inno4Vac project.


The report is a summary of discussions held, and conclusions drawn by this multi-disciplinary group representing agencies from Europe, the UK, and the US.


Key points:

  • The importance of developing harmonised protocols for CHIMs was emphasised, with a focus on ensuring robust, reproducible, and transparent study designs, including adaptive dose-escalation strategies and standardised immunological assays;

  • The need for mandatory trial registration, adherence to FAIR data principles, and early involvement of ethics committees in protocol development was agreed upon to ensure compliance with regulatory and ethical standards and enhance public trust;

  • A commitment to promoting open data sharing through public registries, improving data reuse and aggregation, and fostering collaboration among academia, industry, and regulatory bodies to advance global vaccine and therapeutic research was endorsed, with strict adherence to GDPR principles.


We invite you to read the full article here: https://doi.org/10.1016/j.biologicals.2025.101818 (registration needed).

We gratefully acknowledge all participants for their invaluable contributions and invite you to explore this insightful report.

 

(*) Inno4Vac has several goals, among which is the development of new and improved CHIMs for influenza, Respiratory Syncytial Virus (RSV) and Clostridium difficile that will enable early vaccine efficacy evaluation. ➡️ See more here: www.inno4vac.eu


 

Contact:

Dr. Irina Meln (Project and Innovation Manager at the European Vaccine Initiative)

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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