Controlled human infection trials: Legitimacy and conditions of implementation in France - 17/12/23

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

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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