Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting.

Publication date: Jul 26, 2024

The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity, and cross-protection of different booster vaccination strategies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants, specific for the Australian context. The PICOBOO trial randomises participants to receive one of three COVID-19 booster vaccine brands (Pfizer, Moderna, Novavax) available for use in Australia, where the vaccine brand subtypes vary over time according to the national vaccine roll out strategy, and employs a Bayesian hierarchical modelling approach to efficiently borrow information across consecutive booster doses, age groups and vaccine brand subtypes. Here, we briefly describe the PICOBOO trial structure and report the statistical considerations for the estimands, statistical models and decision making for trial adaptations. This paper should be read in conjunction with the PICOBOO Core Protocol and PICOBOO Sub-Study Protocol 1: Booster Vaccination. PICOBOO was registered on 10 February 2022 with the Australian and New Zealand Clinical Trials Registry ACTRN12622000238774.

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Concepts	Keywords
Actrn12622000238774	Adaptive trial
Australia	Bayesian
Models	COVID-19
Moderna	Immunogenicity
Vaccine	Reactogenicity
	Vaccine

Semantics

Type	Source	Name
disease	VO	COVID-19 vaccine
disease	MESH	COVID-19
disease	IDO	site
disease	VO	vaccination
disease	VO	Severe acute respiratory syndrome coronavirus 2
disease	VO	vaccine
disease	VO	time
disease	VO	report
disease	VO	protocol
disease	MESH	severe acute respiratory syndrome
disease	MESH	infection
disease	VO	effectiveness
disease	VO	efficient
disease	MESH	Infectious Diseases
disease	IDO	quality
disease	VO	document
drug	DRUGBANK	Ranitidine
disease	VO	population
drug	DRUGBANK	Coenzyme M
disease	VO	vaccine dose
disease	IDO	history
disease	VO	manufacturer
drug	DRUGBANK	Hexocyclium
disease	VO	dose
disease	MESH	sid
disease	IDO	intervention
disease	IDO	blood
drug	DRUGBANK	Aspartame
drug	DRUGBANK	Amino acids
disease	VO	frequency
disease	VO	adverse event
disease	IDO	algorithm
drug	DRUGBANK	Ademetionine
disease	VO	effective
disease	MESH	uncertainty
drug	DRUGBANK	Methionine
drug	DRUGBANK	Trestolone
disease	MESH	Pneumonia
disease	VO	Comirnaty
drug	DRUGBANK	Etoperidone
drug	DRUGBANK	Gold
drug	DRUGBANK	Adenosine 5′-phosphosulfate

Original Article

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