Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial

e-pub ahead of print date: 9 May 2022

Published date: August 2022

Additional Information: Funding Information: The study is funded by the UK Government through the National Institute for Health Research (NIHR) and the Vaccine Task Force. The study sponsor is University Hospital Southampton NHS Foundation Trust, Southampton, UK. ChAdOx1 nCoV-19, BNT162b2, and mRNA-1273 used in this study were supplied by the UK Health Security Agency (previously Public Health England). The research is supported by the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, the NIHR Clinical Research Facilities and NIHR Clinical Research Network, and the NIHR-funded National Immunisation Schedule Evaluation Consortium . SNF and MDS are NIHR Senior Investigators. KCh is a Wellcome Trust Investigator (210755/Z/18/Z) and NIHR Senior Investigator Emeritus. The views expressed in this Article are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The investigators would like to thank the UK Medicines and Healthcare products Regulatory Agency and Heath Research Authority for their extraordinary efforts in rapidly reviewing submissions, their attention to detail, and their input into trial design. Specific thanks go to Kirsty Wydenbach, Lisa Campbell, David Jones, Graham McNaughton, Marie-Christine Bielsky, and David Brown at the UK Medicines and Healthcare products Regulatory Agency; to David Carpenter (Chair), Mike Proven (Vice-Chair), and all volunteer officers and members of the South Central, Berkshire Research Ethics Committee; and to Kevin Ahmed and all Heath Research Authority staff who supported the trial. The investigators express their gratitude to all trial participants for their contribution, the UK Vaccine Task Force (Jacinda Kemps), and the trial committees for their invaluable advice. Andrew Ustianowski (Chair), Chris Rogers, and Andrew Riordan serve as the independent members of the Data Monitoring and Safety Committee and RCR is the Chair of the Trial Steering Committee. Funding Information: The study is funded by the UK Government through the National Institute for Health Research (NIHR) and the Vaccine Task Force. The study sponsor is University Hospital Southampton NHS Foundation Trust, Southampton, UK. ChAdOx1 nCoV-19, BNT162b2, and mRNA-1273 used in this study were supplied by the UK Health Security Agency (previously Public Health England). The research is supported by the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, the NIHR Clinical Research Facilities and NIHR Clinical Research Network, and the NIHR-funded National Immunisation Schedule Evaluation Consortium. SNF and MDS are NIHR Senior Investigators. KCh is a Wellcome Trust Investigator (210755/Z/18/Z) and NIHR Senior Investigator Emeritus. The views expressed in this Article are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The investigators would like to thank the UK Medicines and Healthcare products Regulatory Agency and Heath Research Authority for their extraordinary efforts in rapidly reviewing submissions, their attention to detail, and their input into trial design. Specific thanks go to Kirsty Wydenbach, Lisa Campbell, David Jones, Graham McNaughton, Marie-Christine Bielsky, and David Brown at the UK Medicines and Healthcare products Regulatory Agency; to David Carpenter (Chair), Mike Proven (Vice-Chair), and all volunteer officers and members of the South Central, Berkshire Research Ethics Committee; and to Kevin Ahmed and all Heath Research Authority staff who supported the trial. The investigators express their gratitude to all trial participants for their contribution, the UK Vaccine Task Force (Jacinda Kemps), and the trial committees for their invaluable advice. Andrew Ustianowski (Chair), Chris Rogers, and Andrew Riordan serve as the independent members of the Data Monitoring and Safety Committee and RCR is the Chair of the Trial Steering Committee. Publisher Copyright: © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Local EPrints ID: 467964

URI: http://eprints.soton.ac.uk/id/eprint/467964

DOI: doi:10.1016/S1473-3099(22)00271-7

ISSN: 1473-3099

PURE UUID: c361f535-3eda-4196-8de2-e608a693e0ea

ORCID for Alasdair P S Munro: orcid.org/0000-0002-4317-0742

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

ORCID for Saul N Faust: orcid.org/0000-0003-3410-7642

Date deposited: 26 Jul 2022 17:10

Last modified: 23 Nov 2024 03:00