Abstract

Background

The need for coronavirus 2019 (COVID-19) vaccination in different age groups and populations is a subject of great uncertainty and an ongoing global debate. Critical knowledge gaps regarding COVID-19 vaccination include the duration of protection offered by different priming and booster vaccination regimens in different populations, including homologous or heterologous schedules; how vaccination impacts key elements of the immune system; how this is modified by prior or subsequent exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and future variants; and how immune responses correlate with protection against infection and disease, including antibodies and effector and T cell central memory.

Methods

The Platform Trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, multi-arm, Bayesian, adaptive, randomised controlled platform trial. PICOBOO will expeditiously generate and translate high-quality evidence of the immunogenicity, reactogenicity and cross-protection of different COVID-19 priming and booster vaccination strategies against SARS-CoV-2 and its variants/subvariants, specific to the Australian context. While the platform is designed to be vaccine agnostic, participants will be randomised to one of three vaccines at trial commencement, including Pfizer’s Comirnaty, Moderna’s Spikevax or Novavax’s Nuvaxovid COVID-19 vaccine. The protocol structure specifying PICOBOO is modular and hierarchical. Here, we describe the Core Protocol, which outlines the trial processes applicable to all study participants included in the platform trial.

Discussion

PICOBOO is the first adaptive platform trial evaluating different COVID-19 priming and booster vaccination strategies in Australia, and one of the few established internationally, that is designed to generate high-quality evidence to inform immunisation practice and policy. The modular, hierarchical protocol structure is intended to standardise outcomes, endpoints, data collection and other study processes for nested substudies included in the trial platform and to minimise duplication. It is anticipated that this flexible trial structure will enable investigators to respond with agility to new research questions as they arise, such as the utility of new vaccines (such as bivalent, or SARS-CoV-2 variant-specific vaccines) as they become available for use.

Trial registration

Australian and New Zealand Clinical Trials Registry ACTRN12622000238774. Registered on 10 February 2022.

Details

Title
Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)
Author
McLeod, C. 1   VIAFID ORCID Logo  ; Ramsay, J 2 ; Flanagan, K. L. 3 ; Plebanski, M. 4 ; Marshall, H. 5 ; Dymock, M. 2 ; Marsh, J. 2 ; Estcourt, M. J. 6 ; Wadia, U. 1 ; Williams, P. C. M. 7 ; Tjiam, M. C. 8 ; Blyth, C. 9 ; Subbarao, K. 10 ; Nicholson, S. 11 ; Faust, S. 12 ; Thornton, R. B. 8 ; Mckenzie, A. 2 ; Snelling, T. L 6 ; Richmond, P. 13 

1  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230); Centre for Child Health Research, The University of Western Australia, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910); Perth Children’s Hospital, Infectious Diseases Department, Nedlands, Australia (GRID:grid.410667.2) (ISNI:0000 0004 0625 8600) 
2  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230) 
3  Tasmanian Vaccine Trial Centre, Clifford Craig Foundation, Launceston General Hospital, Launceston, Australia (GRID:grid.414659.b); University of Tasmania, School of Health Sciences, College of Health and Medicine, Launceston, Australia (GRID:grid.1009.8) (ISNI:0000 0004 1936 826X); Royal Melbourne Institute of Technology University (RMIT), School of Health and Biomedical Sciences, Melbourne, Australia (GRID:grid.1017.7) (ISNI:0000 0001 2163 3550) 
4  Royal Melbourne Institute of Technology University (RMIT), School of Health and Biomedical Sciences, Melbourne, Australia (GRID:grid.1017.7) (ISNI:0000 0001 2163 3550) 
5  Women’s and Children’s Health Network, North Adelaide, Australia (GRID:grid.431036.3); The University of Adelaide, Robinson Research Institute and Adelaide Medical School, Adelaide, Australia (GRID:grid.1010.0) (ISNI:0000 0004 1936 7304) 
6  University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Camperdown, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X) 
7  University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Camperdown, Australia (GRID:grid.1013.3) (ISNI:0000 0004 1936 834X); Sydney Children’s Hospital Network, Department of Immunology and Infectious Diseases, Westmead, Australia (GRID:grid.414009.8) (ISNI:0000 0001 1282 788X); UNSW, School of Women and Children’s Health, Kensington, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
8  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230); Centre for Child Health Research, The University of Western Australia, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910) 
9  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230); Centre for Child Health Research, The University of Western Australia, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910); Perth Children’s Hospital, Infectious Diseases Department, Nedlands, Australia (GRID:grid.410667.2) (ISNI:0000 0004 0625 8600); University of Western Australia, Division of Paediatrics, School of Medicine, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910) 
10  University of Melbourne, WHO Collaborating Centre for Reference and Research On Influenza, Parkville, Australia (GRID:grid.1008.9) (ISNI:0000 0001 2179 088X) 
11  Serology Laboratory, Victorian Infectious Diseases Research Laboratory, Melbourne, Australia (GRID:grid.1008.9) 
12  National Institute of Health Research, University Hospital Southampton NHS Foundation Trust, Southampton Clinical Research Facility and Biomedical Research Centre, Southampton, UK (GRID:grid.430506.4) (ISNI:0000 0004 0465 4079); University of Southampton, Faculty of Medicine and Institute for Life Sciences, Southampton, UK (GRID:grid.5491.9) (ISNI:0000 0004 1936 9297) 
13  Telethon Kids Institute, Wesfarmers Centre of Vaccines and Infectious Diseases, Nedlands, Australia (GRID:grid.414659.b) (ISNI:0000 0000 8828 1230); Centre for Child Health Research, The University of Western Australia, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910); University of Western Australia, Division of Paediatrics, School of Medicine, Crawley, Australia (GRID:grid.1012.2) (ISNI:0000 0004 1936 7910); Perth Children’s Hospital, General Paediatrics and Immunology Departments, Nedlands, Australia (GRID:grid.410667.2) (ISNI:0000 0004 0625 8600) 
Pages
202
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07225-z
ProQuest document ID
2787985221
Copyright
© Crown 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.