RecruitingPhase 4ACTRN12622000238774

A randomised trial to evaluate the immune response of COVID-19 vaccines in adults and adolescents

Platform Trial In COVID-19 Vaccine BOOsting (PICOBOO) - A single blinded, phase IV, adaptive randomised trial to evaluate the immunogenicity of COVID-19 booster vaccines in adults and adolescents


Sponsor

The Kids Research Institute Australia

Enrollment

1,325 participants

Start Date

Mar 29, 2022

Study Type

Interventional

Conditions

Summary

The PICOBOO study platform is designed to be an adaptive randomised trial to evaluate the safety and effectiveness of COVID-19 booster vaccine strategies in the Australian context. This will enable regulators, researchers and policymakers to flexibly respond to new policy questions as they arise, for example as new vaccine formulations become available and new variants arise in Australia necessitating changes in strategy. This study aims to evaluate, pragmatically and efficiently, the immunogenicity and reactogenicity offered by alternative booster vaccination strategies against SARS-CoV-2. This adaptive trial is designed to allow for perpetual enrolment for as long as is needed to generate high-quality data to inform Australia's national COVID-19 booster vaccination practice and policy.


Eligibility

Sex: Both males and femalesMin Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

The PICOBOO study is an ongoing Australian trial designed to figure out the best strategies for COVID-19 booster vaccinations. As new variants emerge and new vaccine formulations become available, this trial is designed to adapt and keep answering the most current questions. Rather than testing a single new vaccine, it compares different booster combinations to understand which offers the best immune response with the least side effects. Participants give blood and saliva samples at set intervals so researchers can measure how well different booster strategies stimulate the immune system. This ongoing approach means the trial can stay relevant as the pandemic situation changes, giving Australian health authorities the best evidence to guide national vaccine policy. You may be eligible if you are 12 years of age or older, have already completed a primary COVID-19 vaccination series (specific eligibility depends on which vaccine you received and your age), and are registered on the Australian Immunisation Register. People who have received a booster in the last 3 months, those with severe immune system problems, or those with a history of serious allergic reactions to vaccine components are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will receive a single intramuscular dose of vaccine administered by a study nurse: Arm 1: COMIRNATY JN.1 (Bretovameran), 30 µg contained in 0.3ml of undiluted vaccine suspension. Ar

Participants will receive a single intramuscular dose of vaccine administered by a study nurse: Arm 1: COMIRNATY JN.1 (Bretovameran), 30 µg contained in 0.3ml of undiluted vaccine suspension. Arm 2: SPIKEVAX JN.1 (SARS-COV-2 JN.1 mRNA), 50µg contained in 0.5ml of undiluted vaccine suspension. Arm 3: NUVAXOVID JN.1, 5µg of SARS-CoV spike protein adjuvanted with Matrix-M in 0.5ml of undiluted vaccine suspension.


Locations(3)

Perth Children's Hospital - Nedlands

SA,TAS,WA, Australia

Womens and Childrens Hospital - North Adelaide

SA,TAS,WA, Australia

Launceston General Hospital - Launceston

SA,TAS,WA, Australia

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