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

COVID-19

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

Inclusion Criteria9

To be eligible a person must:
Be equal to or over 12 years of age.
.Have received:
two doses of BNT162b2 and be less than 70 years old OR
two doses of ChAdOx1-S and be equal to or over 50 years old OR
two doses of mRNA1273 and be between 12 and 18 years old.
Be willing to receive a COVID-19 vaccine authorised for use (including emergency use authorisation) by the TGA or equivalent regulatory authority.
Be registered on the Australian Immunisation Register (AIR), or otherwise possess evidence of primary vaccination.
Be willing to comply with trial requirements, including the provision of blood and saliva samples at the indicated time intervals.

Exclusion Criteria4

A person is not eligible if they:
Have received a COVID-19 booster vaccine in the preceding 3 months
Individuals who are contraindicated to receive any of the COVID-19 study vaccines. E.g. have a history of anaphylaxis to a vaccine component or myocarditis attributed to previous receipt of a messenger ribonucleic acid (mRNA) vaccine.
Are severely immunocompromised or have a known immunodeficiency.

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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.