Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)
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...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07225-z |
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| author | C. McLeod J Ramsay K. L. Flanagan M. Plebanski H. Marshall M. Dymock J. Marsh M. J. Estcourt U. Wadia P. C. M. Williams M. C. Tjiam C. Blyth K. Subbarao S. Nicholson S. Faust R. B. Thornton A. Mckenzie T. L Snelling P. Richmond |
| author_facet | C. McLeod J Ramsay K. L. Flanagan M. Plebanski H. Marshall M. Dymock J. Marsh M. J. Estcourt U. Wadia P. C. M. Williams M. C. Tjiam C. Blyth K. Subbarao S. Nicholson S. Faust R. B. Thornton A. Mckenzie T. L Snelling P. Richmond |
| author_sort | C. McLeod |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T22:39:21Z |
| format | Article |
| id | doaj.art-6d837e182ed84c918b3162dfc80d7663 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:21Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6d837e182ed84c918b3162dfc80d76632023-03-22T12:17:49ZengBMCTrials1745-62152023-03-0124111410.1186/s13063-023-07225-zCore protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)C. McLeod0J Ramsay1K. L. Flanagan2M. Plebanski3H. Marshall4M. Dymock5J. Marsh6M. J. Estcourt7U. Wadia8P. C. M. Williams9M. C. Tjiam10C. Blyth11K. Subbarao12S. Nicholson13S. Faust14R. B. Thornton15A. Mckenzie16T. L Snelling17P. Richmond18Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteTasmanian Vaccine Trial Centre, Clifford Craig Foundation, Launceston General HospitalSchool of Health and Biomedical Sciences, Royal Melbourne Institute of Technology University (RMIT)Women’s and Children’s Health NetworkWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteSydney School of Public Health, Faculty of Medicine and Health, University of SydneyWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteSydney School of Public Health, Faculty of Medicine and Health, University of SydneyWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteWHO Collaborating Centre for Reference and Research On Influenza, University of MelbourneSerology Laboratory, Victorian Infectious Diseases Research LaboratorySouthampton Clinical Research Facility and Biomedical Research Centre, National Institute of Health Research, University Hospital Southampton NHS Foundation TrustWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteSydney School of Public Health, Faculty of Medicine and Health, University of SydneyWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteAbstract 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.https://doi.org/10.1186/s13063-023-07225-zCOVID-19Booster vaccinationVaccinationImmunisationAdaptive platform trialPolicy |
| spellingShingle | C. McLeod J Ramsay K. L. Flanagan M. Plebanski H. Marshall M. Dymock J. Marsh M. J. Estcourt U. Wadia P. C. M. Williams M. C. Tjiam C. Blyth K. Subbarao S. Nicholson S. Faust R. B. Thornton A. Mckenzie T. L Snelling P. Richmond Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) Trials COVID-19 Booster vaccination Vaccination Immunisation Adaptive platform trial Policy |
| title | Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) |
| title_full | Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) |
| title_fullStr | Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) |
| title_full_unstemmed | Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) |
| title_short | Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) |
| title_sort | core protocol for the adaptive platform trial in covid 19 vaccine priming and boosting picoboo |
| topic | COVID-19 Booster vaccination Vaccination Immunisation Adaptive platform trial Policy |
| url | https://doi.org/10.1186/s13063-023-07225-z |
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