Controlled human infection trials: Legitimacy and conditions of implementation in France - 24/02/24

Doi : 10.1016/j.therap.2023.11.009

Anne-Laure Morin ^a,⁎ , Emmanuelle Blanc ^b, Armelle Phalipon ^a, Pierre-Henri Bertoye ^c, Philippe Amiel ^d,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Cécile Artaud ^e,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Philippe Barthélemy ^f,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Elisabeth Botelho-Nevers ^g,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Soizic Courcier ^h,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Jean-Luc Cracowski ^i,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, François Eisinger ^j,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Remi Forrat ^k,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Alina Gruber ^l,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Euzebiusz Jamrozik ^m,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Odile Launay ^n,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, Claire Le Jeunne ^o,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}, David Simhon ^p,^{^{1
Participants of Round Table “Organizational and regulatory aspects” of Giens Workshops 2023.}}
^a Institut Pasteur, 75015 Paris, France
^b Pfizer, 75014 Paris, France
^c CNRIPH, ministère de la Santé, 75007 Paris, France
^d Inserm, 75654 Paris, France
^e AstraZeneca France, 92400 Courbevoie, France
^f AP–HP, hôpital Antoine-Béclère, 92140 Clamart, France
^g Hôpital Nord, CHU St-Étienne, 42270 St Priest en Jarez, France
^h SC Conseil, 92400 Courbevoie, France
ⁱ Hôpital Michallon, CHU Grenoble-Alpes, 38700 La Tronche, France
^j Institut Paoli-Calmettes, 13009 Marseille, France
^k Sanofi R&D, 69360 Serezin du Rhône, France
^l GSK France, 92500 Rueil-Malmaison, France
^m University of Oxford, United Kingdom; Monash University, University of Melbourne, Melbourne, Australia
ⁿ Université Paris Cité, AP–HP, CIC vaccinologie Cochin Pasteur, hôpital Cochin, Inserm, FCRIN, I REIVAC, 75014 Paris, France
^o Université Paris Cité, AP–HP, Ateliers de Giens, hôpital Cochin, 75014 Paris, France
^p Galien Affaires, 75014 Paris, France

^*Corresponding author. Institut Pasteur, 28, rue du Docteur-Roux, 75724 Paris cedex 15, France.Institut Pasteur28, rue du Docteur-RouxParis cedex 1575724France

Summary

This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called “infectious challenge” trials or “Controlled Human Infection Models”, “CHIM”) recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.

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Keywords : Good clinical practices, CHIM, Healthy volunteers, Vaccines, Infectious challenge, Personal Protection Committee

Plan

Abbreviations

Introduction — controlled human infection clinical trials: a complex subject

Trial definition

Objectives and positioning of the trials

State of the art

Scientific and medical rationale behind CHIM trials in France

Legal and logistic provisions for implementing CHIMs in France

Are there any legal obstacles in France?

What legal qualification should be used for CHIM trials?

What legal status for the pathogen?

Recommendation No. 1

Should investigation sites and the criteria for their authorisation be subject to specific measures?

Recommendation No. 2

Recommendation No. 3

Should good clinical practices be adapted?

Recommendation No. 4

Is it necessary to have specific insurance cover?

Do protocols need to be reviewed by specific ethics committees?

Recommendation No. 5

Ethical and social acceptability requirements for conducting the trials

What financial compensation for volunteers?

Recommendation No. 6

What are the best methods for recruitment, information and consent?

Recommendation No. 7

Acculturation and communication

Recommendation No. 8

Recommendation No. 9

Conclusion

Disclosure of interest

☆	The articles, analyzes and proposals from the Giens Workshops are those of the authors and do not prejudge the proposals of their organization.

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Vol 79 - N° 1

P. 35-45 - janvier 2024 Retour au numéro

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Essais d’infection contrôlée chez la personne humaine : légitimité et conditions de réalisation en France
Anne-Laure Morin, Emmanuelle Blanc, Armelle Phalipon, Pierre-Henri Bertoye, Philippe Amiel, Cécile Artaud, Philippe Barthélemy, Elisabeth Botelho-Nevers, Soizic Courcier, Jean-Luc Cracowski, François Eisinger, Remi Forrat, Alina Gruber, Euzebiusz Jamrozik, Odile Launay, Claire Le Jeunne, David Simhon

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Controlled human infection trials: Legitimacy and conditions of implementation in France - 24/02/24

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