Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults

Accepted/In Press date: 9 March 2022

e-pub ahead of print date: 31 March 2022

Published date: May 2022

Additional Information: Funding Information: We thank the study participants for their time and commitment. The authors gratefully acknowledge support from the UK Vaccine Taskforce of the Department for Business, Energy and Industrial Strategy (BEIS) of Her Majesty’s Government. The funder had no role in the conceptualization, design, data collection, analysis, decision to publish or preparation of the manuscript. We thank the following individuals and organizations for their invaluable contributions to the development and implementation of the SARS-CoV-2 human challenge project: A. Anandakumar, K. Baillie, S. Casserly, S. Cleiff, C. Chu and the NIHR Clinical Research Network staff at the Royal Bolton Hospital; K. Fenton, B. Flutter and the team at the Zayed Centre for Research at Great Ormond Street Hospital; G. Gainsborough, F. Gleason, L. Grey, R. Heyderman, J. Hippisley-Cox, M. Johnson, K. Khunti, M. Mayer, M. Moshe, M. Ocampo, C. Skinner, C. Steves, P. Subudhi, D. Thomas, G. Towers, H. Ward, O. Watson and J. Zhou; the Royal Free London NHS Foundation Trust; the North Central London Critical Care Network (clinical leads D. Howell, G. Smith and G. Bellingan); the Human Infection Challenge Network for Vaccine Development; and ISARIC4C investigators ( https://isaric4c.net/about/authors/ ). We are grateful to Gilead for providing remdesivir for the study. We thank the members of the independent data and safety monitoring board (S. Gordon (chair, Liverpool School of Tropical Medicine), P. Smith (chair, London School of Hygiene and Tropical Medicine), A. Durbin (Johns Hopkins University), F. Hayden (University of Virginia School of Medicine) and D. Dockrell (University of Edinburgh)) and the Medical Oversight Committee/Trial Steering Committee (R.C.R. (chair), D. Ferreira (Liverpool School of Tropical Medicine), H.M., P.O. and A.C.) for their invaluable advice. C. Chiu and P.O. are supported by the NIHR Imperial Biomedical Research Centre award to Imperial College Healthcare NHS Trust and Imperial College London. P.O. is supported by an NIHR Senior Investigator Award (NIHR201385) and a UKRI MRC CIC Award (MR/V028448/1). H.M. is supported by the NIHR Oxford Biomedical Research Centre (NIHR-BRC-1215-20008). R.C.R. is supported by an NIHR Senior Investigator Award (NF-SI-0617-10010) and by the NIHR Southampton Biomedical Research Centre (IS-BRC-1215-20004). The viral swab from which the challenge virus was grown was provided by ISARIC4C, which is funded by the NIHR (award CO-CIN-01), the Medical Research Council (MRC; grant MC_PC_19059) and the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections at the University of Liverpool, in partnership with Public Health England and in collaboration with the Liverpool School of Tropical Medicine and the University of Oxford (NIHR award 200907). The Liverpool Experimental Cancer Medicine Centre provided infrastructure support for this research (grant reference C18616/A25153). This work was also supported by the NIHR Health Protection Research Unit in Respiratory Infections (NIHR award 200927). N.M.F. acknowledges funding from the NIHR Health Protection Research Unit in Modelling and Health Economics, the MRC Centre for Global Infectious Disease Analysis and the Jameel Institute. J.S.N.-V.-T. is seconded to the Department of Health and Social Care (DHSC), England. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, the DHSC or BEIS. Funding Information: We thank the study participants for their time and commitment. The authors gratefully acknowledge support from the UK Vaccine Taskforce of the Department for Business, Energy and Industrial Strategy (BEIS) of Her Majesty’s Government. The funder had no role in the conceptualization, design, data collection, analysis, decision to publish or preparation of the manuscript. We thank the following individuals and organizations for their invaluable contributions to the development and implementation of the SARS-CoV-2 human challenge project: A. Anandakumar, K. Baillie, S. Casserly, S. Cleiff, C. Chu and the NIHR Clinical Research Network staff at the Royal Bolton Hospital; K. Fenton, B. Flutter and the team at the Zayed Centre for Research at Great Ormond Street Hospital; G. Gainsborough, F. Gleason, L. Grey, R. Heyderman, J. Hippisley-Cox, M. Johnson, K. Khunti, M. Mayer, M. Moshe, M. Ocampo, C. Skinner, C. Steves, P. Subudhi, D. Thomas, G. Towers, H. Ward, O. Watson and J. Zhou; the Royal Free London NHS Foundation Trust; the North Central London Critical Care Network (clinical leads D. Howell, G. Smith and G. Bellingan); the Human Infection Challenge Network for Vaccine Development; and ISARIC4C investigators (https://isaric4c.net/about/authors/). We are grateful to Gilead for providing remdesivir for the study. We thank the members of the independent data and safety monitoring board (S. Gordon (chair, Liverpool School of Tropical Medicine), P. Smith (chair, London School of Hygiene and Tropical Medicine), A. Durbin (Johns Hopkins University), F. Hayden (University of Virginia School of Medicine) and D. Dockrell (University of Edinburgh)) and the Medical Oversight Committee/Trial Steering Committee (R.C.R. (chair), D. Ferreira (Liverpool School of Tropical Medicine), H.M., P.O. and A.C.) for their invaluable advice. C. Chiu and P.O. are supported by the NIHR Imperial Biomedical Research Centre award to Imperial College Healthcare NHS Trust and Imperial College London. P.O. is supported by an NIHR Senior Investigator Award (NIHR201385) and a UKRI MRC CIC Award (MR/V028448/1). H.M. is supported by the NIHR Oxford Biomedical Research Centre (NIHR-BRC-1215-20008). R.C.R. is supported by an NIHR Senior Investigator Award (NF-SI-0617-10010) and by the NIHR Southampton Biomedical Research Centre (IS-BRC-1215-20004). The viral swab from which the challenge virus was grown was provided by ISARIC4C, which is funded by the NIHR (award CO-CIN-01), the Medical Research Council (MRC; grant MC_PC_19059) and the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections at the University of Liverpool, in partnership with Public Health England and in collaboration with the Liverpool School of Tropical Medicine and the University of Oxford (NIHR award 200907). The Liverpool Experimental Cancer Medicine Centre provided infrastructure support for this research (grant reference C18616/A25153). This work was also supported by the NIHR Health Protection Research Unit in Respiratory Infections (NIHR award 200927). N.M.F. acknowledges funding from the NIHR Health Protection Research Unit in Modelling and Health Economics, the MRC Centre for Global Infectious Disease Analysis and the Jameel Institute. J.S.N.-V.-T. is seconded to the Department of Health and Social Care (DHSC), England. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, the DHSC or BEIS. Publisher Copyright: © 2022, The Author(s), under exclusive licence to Springer Nature America, Inc.

Related URLs:

• https://livrepository.liverpoo...k/3154936/

Local EPrints ID: 470080

URI: http://eprints.soton.ac.uk/id/eprint/470080

DOI: doi:10.1038/s41591-022-01780-9

ISSN: 1078-8956

PURE UUID: e740e727-be0f-4e5c-affb-46c8919582fb

ORCID for Robert C Read: orcid.org/0000-0002-4297-6728

Date deposited: 03 Oct 2022 16:36

Last modified: 17 Mar 2024 07:15