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

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.

Timeline

Start

2022-12-01

Primary completion

2026-06-30

Completion

2026-12-31

Publications

• Dymock M, McMahon JH, Griffin D, Hagenauer M, Snelling TL, Marsh JA; On behalf of the BOOST-IC Investigator Team. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations: statistical elements and design. Trials. 2025 Jul 25;26(1):256. doi: 10.1186/s13063-025-08965-w.
• Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
• Griffin DWJ, Dymock M, Wong G, Morrissey CO, Lewin SR, Cheng AC, Howard K, Marsh JA, Subbarao K, Hagenauer M, Roney J, Cunningham A, Snelling T, McMahon JH. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial. Trials. 2024 Jul 17;25(1):485. doi: 10.1186/s13063-024-08315-2.

Drugs

Indications