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

Authors :
Robert A Johnson
Nele Berthels
Marc Baay
Adrian Wildfire
Volker Oeppling
Sarah M. Fortune
Isabelle Bekeredjian-Ding
Angela van Diepen
Christoph Conrad
Kawsar R. Talaat
Scott Stibitz
Peter G. Kremsner
Wolfram G. Metzger
Karen Brigitta Goetz
Wim Van Molle
Pieter Neels
Stephen J. Thomas
Yves Levy
Daniel F. Hoft
Beno Nyam Yakubu
Andrew Gorringe
Oleg Krut
Source :
Biologicals. 66:53-61
Publication Year :
2020
Publisher :
Elsevier BV, 2020.

Abstract

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 development than anticipated. Recommendations included: the development of guidelines for human challenge agents; a focus on strain selection, in particular with regard to strain infectivity, stability and purity; the use of whole genome sequencing; a reference repository of challenge agents, the need for early exchange with regulators to ensure acceptability of strain selection and manufacturing for later drug development; sharing of models and challenge agents.

Details

ISSN :
10451056
Volume :
66
Database :
OpenAIRE
Journal :
Biologicals
Accession number :
edsair.doi...........d9335536193ffb1f5e838be489c7aa8e
Full Text :
https://doi.org/10.1016/j.biologicals.2020.04.005