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Third human challenge trial conference, Oxford, United Kingdom, February 6-7, 2020, a meeting report.
Metadata
Journalbiologicals1.801Date
2020 Jun 04
4 months ago
Type
Journal Article
Volume
2020-Jul / 66 : 41-52
Author
Pollard AJ 1, Sauerwein R 2, Baay M 3, Neels P 4, HCT3 speakers and session chairs 5
Affiliation
  • 2. Radboud University Medical Center, the Netherlands. Electronic address: [email protected]
  • 3. P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: [email protected]
  • 4. International Alliance for Biological Standardization, Belgium. Electronic address: [email protected]
  • 5. HCT3 speakers and session chairs
Doi
PMIDMESH
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.
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Biologicalsbiologicals
Metadata
LocationEngland
FromACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD

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