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; Philippe Bejon; Nele Berthels; Susan Bull; Andrew Catchpole; Primus Chi; Roma Chilengi; Rebecca Cox; Hugh Davies; Anna Durbin; Kate Emary; Claudia Emerson; Robert Frenck; Olivia Grimwade; Marcia Hobbs; Gagandeep Kang; Paul Kaye; Kirsty Le Doare; Mike Levine; Helen McShane; Blanche Oguti; Peter Openshaw; Joshua Osowicki; Michael Parker; Dominique Ploin; Chad Porter; Meta Roestenberg; Michael J. Selgelid; Adrian Wildfire

doi:10.1016/j.biologicals.2020.04.004

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, Philippe Bejon, Nele Berthels, Susan Bull, Andrew Catchpole, Primus 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, Mike Levine, Helen McShane, Blanche Oguti, Peter Openshaw, Joshua Osowicki, Michael Parker, Dominique Ploin, Chad Porter, Meta Roestenberg, Michael J. Selgelid, Adrian Wildfire

^*Corresponding author for this work

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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 language	English
Pages (from-to)	41-52
Number of pages	12
Journal	Biologicals
Volume	66
DOIs	https://doi.org/10.1016/j.biologicals.2020.04.004
State	Published - Jul 2020
Externally published	Yes

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Pollard, A. J., Sauerwein, R., Baay, M., Neels, P., Balasingam, S., Bejon, P., Berthels, N., Bull, S., Catchpole, A., Chi, P., Chilengi, R., Cox, R., Davies, H., Durbin, A., Emary, K., Emerson, C., Frenck, R., Grimwade, O., Hobbs, M., ... Wildfire, A. (2020). Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report. Biologicals, 66, 41-52. https://doi.org/10.1016/j.biologicals.2020.04.004

@article{c46e709160c0483daf4e49ffae2ea7ca,

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

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.",

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

note = "Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = jul,

doi = "10.1016/j.biologicals.2020.04.004",

language = "English",

volume = "66",

pages = "41--52",

journal = "Biologicals",

issn = "1045-1056",

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Pollard, AJ, Sauerwein, R, Baay, M, Neels, P, Balasingam, S, Bejon, P, Berthels, N, Bull, S, Catchpole, A, Chi, P, Chilengi, R, Cox, R, Davies, H, Durbin, A, Emary, K, Emerson, C, Frenck, R, Grimwade, O, Hobbs, M, Kang, G, Kaye, P, Le Doare, K, Levine, M, McShane, H, Oguti, B, Openshaw, P, Osowicki, J, Parker, M, Ploin, D, Porter, C, Roestenberg, M, Selgelid, MJ & Wildfire, A 2020, 'Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report', Biologicals, vol. 66, pp. 41-52. https://doi.org/10.1016/j.biologicals.2020.04.004

TY - JOUR

T1 - Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report

AU - Pollard, Andrew J.

AU - Sauerwein, Robert

AU - Baay, Marc

AU - Neels, Pieter

AU - Balasingam, Shobana

AU - Bejon, Philippe

AU - Berthels, Nele

AU - Bull, Susan

AU - Catchpole, Andrew

AU - Chi, Primus

AU - Chilengi, Roma

AU - Cox, Rebecca

AU - Davies, Hugh

AU - Durbin, Anna

AU - Emary, Kate

AU - Emerson, Claudia

AU - Frenck, Robert

AU - Grimwade, Olivia

AU - Hobbs, Marcia

AU - Kang, Gagandeep

AU - Kaye, Paul

AU - Le Doare, Kirsty

AU - Levine, Mike

AU - McShane, Helen

AU - Oguti, Blanche

AU - Openshaw, Peter

AU - Osowicki, Joshua

AU - Parker, Michael

AU - Ploin, Dominique

AU - Porter, Chad

AU - Roestenberg, Meta

AU - Selgelid, Michael J.

AU - Wildfire, Adrian

PY - 2020/7

Y1 - 2020/7

N2 - 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.

AB - 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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U2 - 10.1016/j.biologicals.2020.04.004

DO - 10.1016/j.biologicals.2020.04.004

M3 - Article

C2 - 32505512

AN - SCOPUS:85085744572

SN - 1045-1056

VL - 66

SP - 41

EP - 52

JO - Biologicals

JF - Biologicals

ER -

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

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