Safety and immunogenicity of a self-amplifying RNA vaccine against COVID-19: COVAC1, a phase I, dose-ranging trial

Accepted/In Press date: 16 December 2021

Published date: February 2022

Additional Information: Funding Information: We wish to acknowledge the COVAC1 participants who took part in this first in human vaccine trial, the dedication of the clinic, laboratory and administrative teams, and the oversight that the governance committees provided as the study evolved, including Jonathan Weber who represented the Sponsor, Sue Marlow as Qualified Person, the members who represented the Patients and Public (PPI) and the members of the Independent Data Monitoring Committee established to oversee the planned efficacy trial. Manufacture studies were additionally supported by the NIHR Imperial Biomedical Research Centre (BRC) and the MRC Imperial confidence in Concept. Preclinical toxicology was funded by Department of Health and Social Care using UK Aid funding, managed by the Engineering and Physical Sciences Research Council (EPSRC, grant number: EP/R013764/1). Infrastructure support was provided by the NIHR Imperial Biomedical Research Centre and the NIHR Imperial Clinical Research Facility. We also acknowledge Fondation Dormeur, Vaduz and a gift from the James B. Pendleton Charitable Trust for providing funds to purchase equipment used in these studies. DTD and SMc were supported by a Medical Research Council grant, MC_UU_12023/23 & MC_UU_00004/04. KMP was supported by the NIHR Imperial BRC. We would like to acknowledge also members of the COVAC1 Governance (Independent members): Trial Steering Committee: Robert Lechler (Chair), Janet Darbyshire (Vice Chair), Jeff Almond, Ben Cromarty (PPI), Stuart Elborn; Funding Information: This study was co-funded by grants and gifts from the Medical Research Council UKRI (MC_PC_19076), and the National Institute Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, Restore the Earth. Funding Information: Data will be made available when the trial is complete, upon requests directed to the corresponding author and after approval of a proposal. We wish to acknowledge the COVAC1 participants who took part in this first in human vaccine trial, the dedication of the clinic, laboratory and administrative teams, and the oversight that the governance committees provided as the study evolved, including Jonathan Weber who represented the Sponsor, Sue Marlow as Qualified Person, the members who represented the Patients and Public (PPI) and the members of the Independent Data Monitoring Committee established to oversee the planned efficacy trial. Manufacture studies were additionally supported by the NIHR Imperial Biomedical Research Centre (BRC) and the MRC Imperial confidence in Concept. Preclinical toxicology was funded by Department of Health and Social Care using UK Aid funding, managed by the Engineering and Physical Sciences Research Council (EPSRC, grant number: EP/R013764/1). Infrastructure support was provided by the NIHR Imperial Biomedical Research Centre and the NIHR Imperial Clinical Research Facility. We also acknowledge Fondation Dormeur, Vaduz and a gift from the James B. Pendleton Charitable Trust for providing funds to purchase equipment used in these studies. DTD and SMc were supported by a Medical Research Council grant, MC_UU_12023/23 & MC_UU_00004/04. KMP was supported by the NIHR Imperial BRC. We would like to acknowledge also members of the COVAC1 Governance (Independent members): Trial Steering Committee: Robert Lechler (Chair), Janet Darbyshire (Vice Chair), Jeff Almond, Ben Cromarty (PPI), Stuart Elborn;, Independent Data Monitoring Committee (for planned COVAC2): Peter Smith (Chair), George Griffin, Phil Minor, Moira Whyte; PPI representative on the Trial Management Group: Pro Chatzikyriakou. This study was co-funded by grants and gifts from the Medical Research Council UKRI (MC_PC_19076), and the National Institute Health Research/Vaccine Task Force, Partners of Citadel and Citadel Securities, Sir Joseph Hotung Charitable Settlement, Jon Moulton Charity Trust, Pierre Andurand, Restore the Earth. Publisher Copyright: © 2021 The Authors

Local EPrints ID: 455190

URI: http://eprints.soton.ac.uk/id/eprint/455190

DOI: doi:10.1016/j.eclinm.2021.101262

ISSN: 2589-5370

PURE UUID: 7a8dc876-a045-4dce-8016-29d56485980e

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

Date deposited: 14 Mar 2022 17:52

Last modified: 06 Jun 2024 01:44