Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.

Last updated on 10-2-2022 by Wim Van Molle

Peer reviewed scientific article




Controlled human infection models can be helpful to study pathogenesis and immune responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of the study (‘sliding scale Good Manufacturing Practice’), and, hence, is much more open to speedy drug …

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