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Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO).
C McLeod1,2,3, J Ramsay4, K L Flanagan5,6,7
1Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Australia. charlie.mcleod@health.wa.gov.au.
Trials
|March 19, 2023
Summary
The PICOBOO trial is evaluating COVID-19 (coronavirus 2019) vaccine strategies in Australia. This adaptive platform trial aims to provide evidence on vaccine effectiveness and inform public health policy.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Ongoing global debate surrounds coronavirus 2019 (COVID-19) vaccination needs across diverse populations.
- Critical knowledge gaps exist regarding the duration of protection from various COVID-19 vaccine priming and booster regimens.
- Understanding how vaccination impacts the immune system, especially with prior or subsequent SARS-CoV-2 exposure and variants, remains crucial.
Purpose of the Study:
- To generate high-quality evidence on the immunogenicity, reactogenicity, and cross-protection of different COVID-19 vaccination strategies.
- To address uncertainties in COVID-19 vaccine effectiveness and inform Australian immunisation policy.
- To provide a flexible platform for evaluating new vaccines, including variant-specific ones, as they emerge.
Main Methods:
- The Platform Trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive, randomized controlled platform trial.
- Participants are randomized to receive one of three COVID-19 vaccines: Pfizer's Comirnaty, Moderna's Spikevax, or Novavax's Nuvaxovid.
- A modular and hierarchical protocol structure standardizes data collection and outcomes for nested substudies.
Main Results:
- The trial is designed to expeditiously generate and translate evidence on vaccine performance against SARS-CoV-2 and its variants.
- Data will inform the duration of protection, immune system impact, and correlation of immune responses with protection against infection and disease.
- Results will be specific to the Australian context, considering homologous and heterologous boosting strategies.
Conclusions:
- PICOBOO is the first adaptive platform trial of its kind in Australia, contributing to international efforts.
- The trial's flexible structure allows for agile responses to emerging research questions and new vaccine technologies.
- Evidence generated will guide COVID-19 immunisation practices and policies, addressing critical knowledge gaps.
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