Considerations on the principles of development and manufacturing qualities of challenge agents for use in human infection models
A consortium of international experts with experience in the production of challenge agents, performance of challenge studies, and/or good manufacturing practices (GMP) was established to draft a considerations document, intended to discuss fundamental principles of selection, characterisation, manufacture, quality control and storage of challenge agents for international reference. In the absence of clear international guidance on this topic, the principles outlined in this document should be considered for implementation with the context of the pathogen and setting taken into consideration and for the purposes of improving volunteer safety, model reliability, and for interactions with regulatory agencies or other bodies which oversee human challenge studies. This document can be utilised across high-, middle- and low-income countries and can be applied whether the agent is manufactured in a certified GMP facility or in an academic laboratory by trained personnel with sufficient facilities, appropriate quality control measures and other best practices.
Author affiliations
(1) hVIVO: Carine La, Alex Mann, Alan Bell, Bruno Speder
(2) IABS-EU: Jean-Hugues Trouvin, Pieter Neels
(3) European Vaccine Initiative – EVI: Hilde Depraetere
(4) John Hopkins Bloomberg School of Public Health: Kawsar R. Talaat
(5) Naval Medical Research Center: Chad K. Porter
(6) PATH: Louis Bourgeois
(7) Leiden University Medical Center: Meta Roestenberg
(8) Tübingen University and Centre de Recherches Médicales de Lambarene: Peter Kremsner
(9) Oxford University Clinical Research Unit: Evelyne Kestelyn
(10) NAFDAC: Beno N. Yakubu
(11) Translational Health Science and Technology Institute: Amrita Sekkar
(12) The Wellcome Trust Research Laboratory Division of Gastrointestinal Sciences, Christian Medical College: Gagandeep Kang
Carine La
Roles: Conceptualization, Methodology, Project Management, Data Collection, Writing – Original Draft Preparation, Review & Editing
Alan Bell
Roles: Methodology, Review & Editing
Consortium members
Roles: Review
Alex Mann (corresponding author)
Roles: Conceptualisation, Methodology, Funding acquisition, Supervision, Project management, Writing, Review & Editing
Edit 14/04/2022 to correct author list
