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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)
Trials, Volume 24, No. 1, Article 202, Year 2023
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Description
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. © 2023, Crown.
Authors & Co-Authors
McLeod, Charlie
Australia, Perth
Telethon Kids Institute
Australia, Perth
The University of Western Australia
Australia, Perth
Perth Children's Hospital
Flanagan, Katie L.
Australia, Launceston
Launceston General Hospital
Australia, Hobart
University of Tasmania
Australia, Melbourne
Rmit University
Plebanski, Magdalena
Australia, Melbourne
Rmit University
Marshall, Helen Siobhan
Australia, Adelaide
Women's and Children's Health Network
Australia, Adelaide
The University of Adelaide
Marsh, Julie A.
Australia, Perth
Telethon Kids Institute
Wadia, Ushma D.
Australia, Perth
Telethon Kids Institute
Australia, Perth
The University of Western Australia
Australia, Perth
Perth Children's Hospital
Williams, Phoebe C.M.
Australia, Sydney
The University of Sydney
Australia, Sydney
The Children's Hospital at Westmead
Australia, Sydney
Unsw Sydney
Blyth, Christopher C.
Australia, Perth
Telethon Kids Institute
Australia, Perth
The University of Western Australia
Australia, Perth
Perth Children's Hospital
Faust, Saul N.
United Kingdom, Southampton
University Hospital Southampton Nhs Foundation Trust
United Kingdom, Southampton
University of Southampton
McKenzie, Anne E.
Australia, Perth
Telethon Kids Institute
Snelling, Thomas Laurence
Australia, Sydney
The University of Sydney
Richmond, Peter
Australia, Perth
Telethon Kids Institute
Australia, Perth
The University of Western Australia
Australia, Perth
Perth Children's Hospital
Statistics
Authors: 12
Affiliations: 15
Identifiers
Doi:
10.1186/s13063-023-07225-z
ISSN:
17456215
Research Areas
Covid
Health System And Policy
Study Design
Randomised Control Trial
Grounded Theory