Symposium on "Experimental infection of healthy volunteers" on June 30: an ethical and regulatory framework

Clinical trials that involve a phase of experimental infection of healthy volunteers are currently carried out in several countries, including the United States and Australia as well as some European countries such as the Netherlands, the United Kingdom and Germany.

These trials, known as controlled human infection studies, help speed up the development of vaccines and treatments and advance medical and scientific knowledge. Studies of this type are not conducted in France, but several public and private French organizations have been associated with such trials abroad. In 2016 and 2017, WHO published guidelines that provide an ethical foundation and lay down technical conditions to guarantee the safety of volunteers and the community. The WHO working group particularly indicated that it did not see a moral or ethical difference between controlled human infection studies and Phase I trials during which a vaccine or drug candidate is administered to humans for the first time. In line with this opinion, controlled human infection studies should be conceivable in France, as long as they do not clash with specific national ethical or sociological norms.

The Institut Pasteur, through its Executive Scientific Division and Medical Department, in collaboration with the Legal Affairs Department and the Ethics Unit within that department, and the Technology Transfer and Industrial Partnership Department, in conjunction with representatives from the Paris Public Hospital Network (AP-HP), are pleased to invite you to a symposium organized on this topic. The symposium, entitled "Experimental infection of healthy volunteers – an ethical and regulatory framework. International experience and situation in France," will be held from 4pm onwards on June 30 and will be followed by a question and answer session.

Download the program

The event is free but prior registration is required; please email Lydie Texier: lydie.texier@pasteur.fr