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Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
Sponsor: Monash University
Summary
Despite the greater risk of adverse COVID-19 outcomes, antibody and cell-mediated immune responses to COVID-19 vaccines vary amongst immunocompromised (IC) people and are poorly defined. IC hosts were largely excluded from the COVID-19 vaccine registration trials, though many countries recommend additional and booster doses of vaccination in this group. BOOST-IC is an adaptive randomised clinical trial (RCT) to assess the immunogenicity and safety of additional COVID-19 vaccine doses in immunocompromised (IC) people, including people with HIV, solid organ transplants (SOT) recipients or those with haematological malignancies. Briefly, the study aims to generate high-quality evidence on the immunogenicity and safety of alternative COVID-19 booster strategies against SARS-CoV-2 for IC people in Australia.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
960
Start Date
2022-12-01
Completion Date
2026-12-31
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Pfizer Bivalent COVID-19 Vaccine
One or Two doses three months apart, per manufacturer's recommendations.
Moderna Bivalent mRNA vaccine
One or Two doses three months apart, per manufacturer's recommendations.
Locations (13)
St Vincents Hospital
Darlinghurst, New South Wales, Australia
Prince Of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St Vincents Hospital
Fitzroy, Victoria, Australia
University Geelong Hospital
Geelong, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia