The Platform trial In COVID-19 vaccine priming and BOOsting (PICOBOO) booster vaccination substudy protocol.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-11-01 DOI:10.1186/s13063-024-08456-4

McLeod C, Dymock M, Flanagan Kl, Plebanski M, Marshall H, Marsh J, Estcourt Mj, Ramsay J, Wadia U, Williams Pcm, Tjiam Mc, Blyth C, Subbarao K, Nicholson S, Faust S N, Thornton Rb, Mckenzie A, Snelling T, Richmond P

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Abstract

Background: Coronavirus-2019 (COVID-19) vaccination in Australia commenced in February 2021. The first vaccines recommended for use were AZD1222 and BNT162b2, both delivered as a two-dose primary schedule. In the absence of sustained immunity following immunisation, recommendations for booster vaccination have followed. It is likely that periodic boosting will be necessary for at least some Australians, but it is unknown what the optimal booster vaccines and schedules are or for whom vaccination should be recommended.

Methods: The Platform Trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, multi-arm, randomised, Bayesian adaptive platform trial evaluating different booster vaccine interventions in immunocompetent children and adults, stratified by their primary vaccination schedule and age. Participants are randomised to receive one of three licensed COVID-19 booster vaccines available for use in Australia. PICOBOO aims to generate evidence about the immunogenicity, reactogenicity, and cross-protection of different booster vaccine strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants/subvariants. The protocol structure specifying PICOBOO is modular and hierarchical. We have previously published the PICOBOO core (master) protocol. Here, we detail the substudy protocol which outlines the study processes which are specific to PICOBOO participants enrolled in the booster vaccination substudy.

Discussion: PICOBOO is an adaptive platform trial evaluating different COVID-19 booster vaccination strategies to generate evidence to inform immunisation practice and policy. The modular and flexible protocol structure is intended to enable investigators to respond with agility to new research questions as they arise, such as immunogenicity targeting emergent virus variants, and the immunogenicity and reactogenicity of new vaccines as they become available for use.

Trial registration: Australian and New Zealand Clinical Trials Register ACTRN12622000238774; registered on 10/02/2022. Protocol V8.0_23112023.

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平台试验中的 COVID-19 疫苗接种启动和 BOOsting（PICOBOO）加强接种子研究方案。

背景：澳大利亚于 2021 年 2 月开始接种冠状病毒-2019（COVID-19）疫苗。首批推荐使用的疫苗是 AZD1222 和 BNT162b2，均为两剂初次接种。在免疫接种后没有持续免疫力的情况下，建议进行加强免疫接种。至少有一部分澳大利亚人可能需要定期加强免疫，但目前尚不清楚最佳的加强免疫疫苗和计划是什么，也不知道应该为哪些人推荐加强免疫：COVID-19 启动和加强接种平台试验（PICOBOO）是一项多地点、多臂、随机、贝叶斯适应性平台试验，对免疫功能正常的儿童和成人的不同加强接种疫苗干预措施进行评估，并根据其主要接种计划和年龄进行分层。参与者被随机分配接种三种在澳大利亚上市的 COVID-19 强化疫苗中的一种。PICOBOO 的目的是为不同加强免疫策略针对严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 及其变种/亚变种的免疫原性、反应原性和交叉保护提供证据。规定 PICOBOO 的协议结构是模块化和分层的。我们曾发布过 PICOBOO 核心（主）协议。在此，我们将详细介绍子研究方案，该方案概述了参加加强接种子研究的 PICOBOO 参与者所特有的研究过程：PICOBOO是一项适应性平台试验，对不同的COVID-19加强免疫策略进行评估，为免疫实践和政策提供依据。模块化和灵活的方案结构旨在使研究人员能够灵活应对出现的新研究问题，如针对新出现的病毒变种的免疫原性，以及新疫苗投入使用后的免疫原性和反应原性：试验注册：澳大利亚和新西兰临床试验注册中心 ACTRN12622000238774；注册日期：2022 年 2 月 10 日。协议 V8.0_23112023。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.