Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

e-pub ahead of print date: 6 December 2021

Published date: 1 January 2022

Additional Information: Funding Information: The study is funded by the UK Government through the National Institute for Health Research, the Vaccine Task Force, and the Coalition for Epidemic Preparedness Innovations. This research was supported by the NIHR Oxford Biomedical Research Centre, NIHR Guy's and St Thomas' Biomedical Research Centre, NIHR King's Clinical Research Facility and NIHR Policy Research Programme (PR-R17-0916-22001), the Southampton NIHR Biomedical Research Centre and Southampton NIHR Clinical Research Facility and delivered through the NIHR-funded National Immunisation Schedule Evaluation Consortium. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. NVX vaccine was supplied for use in the trial by Novavax. MDS and SNF are NIHR senior investigators. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The investigators express their gratitude for the contribution of all trial participants, and for the invaluable advice of the data safety monitoring board. We additionally acknowledge the broader support from the various teams within the University of Oxford, including the Department of Paediatrics, Clinical Trials Research Governance, Research Contracts, and the Public Affairs Directorate. Funding Information: MDS acts on behalf of the University of Oxford as an investigator on studies funded or sponsored by vaccine manufacturers, including AstraZeneca, GlaxoSmithKline, Pfizer, Novavax, Janssen, Medimmune, and MCM. He receives no personal financial payment for this work. JSN-V-T is seconded to the Department of Health and Social Care, England. AMC and DMF are investigators on studies funded by Pfizer and Unilever. They receive no personal financial payment for this work. AF is a member of the Joint Committee on Vaccination and Immunisation and chair of the WHO European Technical Advisory Group of Experts on Immunisation. He is an investigator or provides consultative advice on clinical trials and studies of COVID-19 vaccines produced by AstraZeneca, Janssen, Valneva, Pfizer, and Sanofi, and of other vaccines from these and other manufacturers, including GlaxoSmithKline, VPI Pharmaceuticals, Takeda, and Bionet Asia. He receives no personal remuneration or benefits for any of this work. SNF acts on behalf of University Hospital Southampton NHS Foundation Trust as an investigator or provides consultative advice on clinical trials and studies of COVID-19 and other vaccines funded or sponsored by vaccine manufacturers, including Janssen, Pfizer, AstraZeneca, GlaxoSmithKline, Novavax, Seqirus, Sanofi, Medimmune, Merck, and Valneva. He receives no personal financial payment for this work. PTH acts on behalf of St George's University of London as an investigator on clinical trials of COVID-19 vaccines funded or sponsored by vaccine manufacturers, including Janssen, Pfizer, AstraZeneca, Novavax, and Valneva. He receives no personal financial payment for this work. CAG acts on behalf of University Hospitals Birmingham NHS Foundation Trust as an investigator on clinical trials and studies of COVID-19 and other vaccines funded or sponsored by vaccine manufacturers, including Janssen, Pfizer, AstraZeneca, Novavax, CureVac, Moderna, and Valneva. He receives no personal financial payment for this work. VL acts on behalf of University College London Hospitals NHS Foundation Trust as an investigator on clinical trials of COVID-19 vaccines funded or sponsored by vaccine manufacturers including Pfizer, AstraZeneca, and Valneva. He receives no personal financial payment for this work. TL is named as an inventor on a patent application covering the ChAd vaccine and is an occasional consultant to Vaccitech, unrelated to this work. ALG is named as an inventor on a patent covering use of a particular promoter construct that is often used in ChAdOx1-vectored vaccines and is incorporated in the ChAdOx1 nCoV-19 vaccine. ALG benefits from royalty income paid to the University of Oxford from sales of this vaccine by AstraZeneca and its sublicensees under the University's revenue sharing policy. Oxford University has entered into a partnership with AstraZeneca for further development of ChAdOx1 nCoV-19. All other authors declare no competing interests.

Local EPrints ID: 454076

URI: http://eprints.soton.ac.uk/id/eprint/454076

DOI: doi:10.1016/S0140-6736(21)02718-5

ISSN: 0140-6736

PURE UUID: 29acc976-8e4f-4072-a3b6-41ef1f862208

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

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

Date deposited: 28 Jan 2022 17:31

Last modified: 16 Aug 2024 01:45