Clinical Trial

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

Study acronym: BOOST-IC
Active, Not Recruiting Phase 3
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Record status
This record was last updated October 3, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-09-25; most recent amendment 2025-09-30.
Status change: Recruiting → Active, Not Recruiting 2025-09-30
Status change: Not Yet Recruiting → Recruiting 2023-01-31
Trial Details
NCT Number NCT05556720
Lead Sponsor Monash University
Collaborators: University of Sydney, University of Melbourne
Conditions HIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Multiple Myeloma, COVID-19 Vaccines
Enrollment 960 participants
Start Date 2022-12-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-03