Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report

Andrew J. Pollard, Robert Sauerwein, Marc Baay, Pieter Neels, Shobana Balasingam, Philip Bejon, Nele Berthels, Susan Bull, Andrew Catchpole, Primus C. Chi, Roma Chilengi, Rebecca Cox, Hugh Davies, Anna Durbin, Kate Emary, Claudia Emerson, Robert Frenck, Olivia Grimwade, Marcia Hobbs, Gagandeep KangPaul Kaye, Kirsty Le Doare, Myron M. Levine, Helen McShane, Blanche Oguti, Peter Openshaw, Joshua Osowicki, Michael Parker, Dominique Ploin, Chad Porter, Meta Roestenberg, Michael J. Selgelid, Adrian Wildfire

Research output: Contribution to journalArticleOtherpeer-review

Abstract

The third Human Challenge Trial Meeting brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from Low- and Middle-Income Countries. Controlled human infection models (CHIMs) can be helpful to study pathogenesis and for the development of vaccines. As challenge agents are used to infect healthy volunteers, ethical considerations include that the challenge studies need to be safe and results should be meaningful. The meeting provided a state-of-the-art overview on a wide range of CHIMs, including viral, bacterial and parasitic challenge agents. Recommendations included globally aligned guidance documents for CHIM studies; further definition of a CHIM, based on the challenge agent used; standardization of methodology and study endpoints; capacity building in Low- and Middle-Income Countries, in performance as well as regulation of CHIM studies; guidance on compensation for participation in CHIM studies; and preparation of CHIM studies, with strong engagement with stakeholders.

Original languageEnglish
Pages (from-to)41-52
Number of pages12
JournalBiologicals
Volume66
DOIs
Publication statusPublished - 2020

Cite this