Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report

Irina Meln; Victor Cnossen; Nicoletta Corti; Arno Andeweg; Marc Baay; Christopher Chiu; John Coia; Oliver Cornely; Rebecca J. Cox; Dileep Dasyam; Sigrid C. J. De Keersmaecker; Meagan Deming; Joanna Waldock; Othmar G. Engelhardt; Manman Guo; Okba Haj-Ali Saflo; Annefleur Hensen; Rienk Jeeninga; Simon Kolstoe; Oleg Krut; Ed J. Kuijper; Lorna Leal; Natalie Mazur; Kristin G. I. Mohn; Sandra Morel; Ab Osterhaus; Augustin Portela Moreira; Wiep Klaas Smits; Saranya Sridhar; Danny Toomey; Joop van Gerven; Maria J. G. T. Vehreschild; Juan Pablo Yarzabal; Paul Zimmer-Harwood; Pieter Neels; Ole F. Olesen; Meta Roestenberg; Ingrid M. C. Kamerling

doi:10.1016/j.biologicals.2025.101818

Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report

Irina Meln, Victor Cnossen, Nicoletta Corti, Arno Andeweg, Marc Baay, Christopher Chiu, John Coia, Oliver Cornely, Rebecca J. Cox, Dileep Dasyam, Sigrid C. J. De Keersmaecker, Meagan Deming, Joanna Waldock, Othmar G. Engelhardt, Manman Guo, Okba Haj-Ali Saflo, Annefleur Hensen, Rienk Jeeninga, Simon Kolstoe, Oleg KrutEd J. Kuijper, Lorna Leal, Natalie Mazur, Kristin G. I. Mohn, Sandra Morel, Ab Osterhaus, Augustin Portela Moreira, Wiep Klaas Smits, Saranya Sridhar, Danny Toomey, Joop van Gerven, Maria J. G. T. Vehreschild, Juan Pablo Yarzabal, Paul Zimmer-Harwood, Pieter Neels, Ole F. Olesen, Meta Roestenberg, Ingrid M. C. Kamerling

School of Dental, Health and Care Professions

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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.

Original language	English
Article number	101818
Number of pages	10
Journal	Biologicals
Volume	90
Early online date	17 Jan 2025
DOIs	https://doi.org/10.1016/j.biologicals.2025.101818
Publication status	Early online - 17 Jan 2025

Keywords

Influenza virus
Respiratory syncytial virus
Clostridioides difficile
Controlled human infection studies
Human challenge trials
CHIM

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10.1016/j.biologicals.2025.101818

FINAL 1-s2.0-S1045105625000090-mainFinal published version, 881 KBLicence: CC BY

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Meln, I., Cnossen, V., Corti, N., Andeweg, A., Baay, M., Chiu, C., Coia, J., Cornely, O., Cox, R. J., Dasyam, D., De Keersmaecker, S. C. J., Deming, M., Waldock, J., Engelhardt, O. G., Guo, M., Haj-Ali Saflo, O., Hensen, A., Jeeninga, R., Kolstoe, S., ... Kamerling, I. M. C. (2025). Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report. Biologicals, 90, Article 101818. Advance online publication. https://doi.org/10.1016/j.biologicals.2025.101818

@article{514304b148b643c6bc6dd4bc8f29a149,

title = "Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report",

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.",

keywords = "Influenza virus, Respiratory syncytial virus, Clostridioides difficile, Controlled human infection studies, Human challenge trials, CHIM",

author = "Irina Meln and Victor Cnossen and Nicoletta Corti and Arno Andeweg and Marc Baay and Christopher Chiu and John Coia and Oliver Cornely and Cox, {Rebecca J.} and Dileep Dasyam and {De Keersmaecker}, {Sigrid C. J.} and Meagan Deming and Joanna Waldock and Engelhardt, {Othmar G.} and Manman Guo and {Haj-Ali Saflo}, Okba and Annefleur Hensen and Rienk Jeeninga and Simon Kolstoe and Oleg Krut and Kuijper, {Ed J.} and Lorna Leal and Natalie Mazur and Mohn, {Kristin G. I.} and Sandra Morel and Ab Osterhaus and Moreira, {Augustin Portela} and Smits, {Wiep Klaas} and Saranya Sridhar and Danny Toomey and {van Gerven}, Joop and Vehreschild, {Maria J. G. T.} and Yarzabal, {Juan Pablo} and Paul Zimmer-Harwood and Pieter Neels and Olesen, {Ole F.} and Meta Roestenberg and Kamerling, {Ingrid M. C.}",

note = "Copyright {\textcopyright} 2025. Published by Elsevier Ltd.",

year = "2025",

month = jan,

day = "17",

doi = "10.1016/j.biologicals.2025.101818",

language = "English",

volume = "90",

journal = "Biologicals",

issn = "1045-1056",

publisher = "Elsevier",

}

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 & Kamerling, IMC 2025, 'Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report', Biologicals, vol. 90, 101818. https://doi.org/10.1016/j.biologicals.2025.101818

TY - JOUR

T1 - Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report

AU - Meln, Irina

AU - Cnossen, Victor

AU - Corti, Nicoletta

AU - Andeweg, Arno

AU - Baay, Marc

AU - Chiu, Christopher

AU - Coia, John

AU - Cornely, Oliver

AU - Cox, Rebecca J.

AU - Dasyam, Dileep

AU - De Keersmaecker, Sigrid C. J.

AU - Deming, Meagan

AU - Waldock, Joanna

AU - Engelhardt, Othmar G.

AU - Guo, Manman

AU - Haj-Ali Saflo, Okba

AU - Hensen, Annefleur

AU - Jeeninga, Rienk

AU - Kolstoe, Simon

AU - Krut, Oleg

AU - Kuijper, Ed J.

AU - Leal, Lorna

AU - Mazur, Natalie

AU - Mohn, Kristin G. I.

AU - Morel, Sandra

AU - Osterhaus, Ab

AU - Moreira, Augustin Portela

AU - Smits, Wiep Klaas

AU - Sridhar, Saranya

AU - Toomey, Danny

AU - van Gerven, Joop

AU - Vehreschild, Maria J. G. T.

AU - Yarzabal, Juan Pablo

AU - Zimmer-Harwood, Paul

AU - Neels, Pieter

AU - Olesen, Ole F.

AU - Roestenberg, Meta

AU - Kamerling, Ingrid M. C.

PY - 2025/1/17

Y1 - 2025/1/17

N2 - 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.

AB - 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.

KW - Influenza virus

KW - Respiratory syncytial virus

KW - Clostridioides difficile

KW - Controlled human infection studies

KW - Human challenge trials

KW - CHIM

U2 - 10.1016/j.biologicals.2025.101818

DO - 10.1016/j.biologicals.2025.101818

M3 - Article

C2 - 39824043

SN - 1045-1056

VL - 90

JO - Biologicals

JF - Biologicals

M1 - 101818

ER -

Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies - a stakeholder meeting report

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Keywords

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