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Four Key Reports highlighting regulatory and ethical aspects of the Controlled Human Infection Models

The Inno4Vac project aims to develop advanced and safe Controlled Human Infection Models (CHIMs) that can improve and accelerate vaccine development. Regulation of CHIM development is a new area of regulatory science and stakeholder engagement is a crucial aspect of the Inno4Vac project to ensure an open dialogue between the Inno4Vac Consortium and external experts, including clinical and healthcare professionals, regulatory agencies, and other initiatives.    


February 2024


European Vaccine Initiative (EVI) and International Alliance for Biological Standardization-Europe (IABS-EU) have organised several stakeholder meetings resulting in four publications highlighting significant advancements in the field of Controlled Human Infection Models (CHIMs). 

The first publication, "Regulatory Workshop on Challenge Strain Development and GMP Manufacture: A Stakeholder Meeting Report”, stemming from an event held October 4th 2022, offers insights into challenge strain development and Good Manufacturing Practice (GMP) manufacture, crucial for advancing CHIM research. It addresses key considerations and recommendations stemming from the workshop discussions, guiding developers on regulatory requirements and guidelines.

The second and third publications stem from the 4th IABS CHIM Conference held in Mombasa, Kenya, 22-24th May 2023:

>> "Fourth Controlled Human Infection Model (CHIM) Meeting: CHIMs in Endemic Countries” focusing on endemic countries, discusses historical, ethical aspects and the challenges faced in Africa, including regulatory complexities and inequity in funding and career development for African scientists. This report sheds light on valuable initiatives and collaborations aimed at strengthening local skills and capabilities and promoting regional ownership of research activities.

>> "Fourth Controlled Human Infection Model (CHIM) Meeting: CHIM Regulatory Issues" encapsulates discussions addressing regulatory challenges in CHIM trials. It provides valuable insights into overcoming regulatory hurdles and emphasises the need for comprehensive regulatory frameworks to navigate complexity effectively.

Lastly, the fourth publication stems from an event held 30th May 2023, jointly organised by IABS-EU, EVI and hosted by the Belgian Ministry of Health. It focuses on the ethical considerations involved in obtaining approval for CHIM clinical trial protocols. Titled "Ethical Approval for Controlled Human Infectious Model Clinical Trial Protocols", this publication underscores the importance of ethical rigour and adherence to regulatory standards, aiming to uphold participant safety and public trust in research.

These reports represent significant contributions to the field of CHIM research and initiatives aimed at advancing ethical, safe, and high-quality CHIM studies. We extend our sincere gratitude to all participants for their invaluable contributions and invite you to explore these insightful reports. 

Subtopic 2 is dedicated to the development of new and improved controlled human infection models (CHIM) for influenza, Respiratory Syncytial Virus (RSV) and Clostridium difficile that will enable early vaccine efficacy evaluation. ➡️ See more about subtopic 2 here.



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 ( 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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