Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Australia.
Infectious Diseases Department, Perth Children's Hospital, Nedlands, Australia.
Trials. 2024 Nov 1;25(1):735. doi: 10.1186/s13063-024-08456-4.
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.
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.
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.
Australian and New Zealand Clinical Trials Register ACTRN12622000238774; registered on 10/02/2022. Protocol V8.0_23112023.
澳大利亚于 2021 年 2 月开始接种 2019 年冠状病毒病（COVID-19）疫苗。推荐使用的首批疫苗为阿斯利康 AZD1222 和辉瑞 BNT162b2，均采用两剂初级接种方案。由于接种后免疫持续时间不持久，因此建议进行加强免疫接种。对于至少一些澳大利亚人来说，定期加强免疫可能是必要的，但尚不清楚最佳的加强疫苗和方案是什么，以及应该向谁推荐接种疫苗。
COVID-19 初级和加强免疫的平台试验（PICOBOO）是一项多地点、多臂、随机、贝叶斯适应性平台试验，评估免疫功能正常的儿童和成人中不同加强疫苗干预措施的效果，这些干预措施按其初级疫苗接种方案和年龄进行分层。参与者被随机分配接受澳大利亚可用的三种许可 COVID-19 加强疫苗之一。PICOBOO 的目的是针对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）及其变体/亚变体生成不同加强疫苗策略的免疫原性、反应原性和交叉保护的证据。指定 PICOBOO 的方案结构具有模块化和分层性。我们之前已经发表了 PICOBOO 核心（主）方案。在这里，我们详细介绍了子研究方案，该方案概述了特定于 PICOBOO 参与者参加加强免疫接种子研究的研究过程。
PICOBOO 是一项适应性平台试验，评估不同的 COVID-19 加强疫苗接种策略，以生成证据，为免疫实践和政策提供信息。模块化和灵活的方案结构旨在使研究人员能够灵活应对新出现的研究问题，例如针对新出现病毒变体的免疫原性目标，以及随着新疫苗的出现，它们的免疫原性和反应原性。
澳大利亚和新西兰临床试验注册 ACTRN12622000238774；注册于 2022 年 2 月 10 日。方案 V8.0_23112023。
