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ACTIVE NOT RECRUITING
NCT05556720
PHASE3

Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial

Sponsor: Monash University

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pfizer Bivalent COVID-19 Vaccine

One or Two doses three months apart, per manufacturer's recommendations.

BIOLOGICAL

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