1. Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - A stakeholder meeting report.
- Author
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Meln I, Cnossen V, Corti N, Andeweg A, Baay M, Chiu C, Coia J, Cornely O, Cox RJ, Dasyam D, De Keersmaecker SCJ, Deming M, Waldock J, Engelhardt OG, Guo M, Haj-Ali Saflo O, Hensen A, Jeeninga R, Kolstoe S, Krut O, Kuijper EJ, Leal L, Mazur N, Mohn KGI, Morel S, Osterhaus A, Moreira AP, Smits WK, Sridhar S, Toomey D, van Gerven J, Vehreschild MJGT, Yarzabal JP, Zimmer-Harwood P, Neels P, Olesen OF, Roestenberg M, and Kamerling IMC
- Abstract
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs. Key discussions focused on refining trial protocols to balance statistical power with participant burden, overseen by a data safety monitoring board. The meeting emphasised the importance of harmonizing CHIM protocols to ensure robust, reproducible, and transparent research. Mandatory trial registration and adherence to the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles were recommended to enhance data reuse and scientific value. This report consolidates efforts to standardise CHIM protocols, essential for accelerating therapeutic innovations and advancing global health research., Competing Interests: Declaration of competing interest Dileep Dasyam, Okba Haj-Ali Saflo, Sandra Morel, and Juan Pablo Yarzabal are employed by GSK and hold financial equities in GSK. These authors declare no other financial and non-financial relationships and activities. All other authors declare no competing interests., (Copyright © 2025. Published by Elsevier Ltd.)
- Published
- 2025
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