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

Study acronym: BOOST-IC
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Lead sponsor: Bayside Health to Monash University Primary completion date: Feb 28, 2024 to Jun 30, 2026 · Trial status: Recruiting to Active, Not Recruiting · Study sites: 1 to 13 · 4 morev4 Show 7 more changesShow less
    • Primary completion date: Feb 28, 2024 to Jun 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 13
    • Completion date: Dec 31, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 37 words
    • Study description shortened, about 6 words
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Study description expanded, about 17 wordsv3 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 1, 2022 to Dec 1, 2022 · Interventions: BNT162b2 (Biological), NVX-COV2373 (Biological), mRNA-1273 (Biological) to Moderna Bivalent mRNA vaccine (Biological), Pfizer Bivalent COVID-19 Vaccine (Biological) · Eligibility criteria expanded, about 26 words · 3 morev2 Show 6 more changesShow less
    • Start date changed from estimate of Oct 1, 2022 to Dec 1, 2022
    • Interventions: BNT162b2 (Biological), NVX-COV2373 (Biological), mRNA-1273 (Biological) to Moderna Bivalent mRNA vaccine (Biological), Pfizer Bivalent COVID-19 Vaccine (Biological)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 15 to 16
    • Study description expanded, about 18 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Monash University
29 trials monitored
See 3 trials at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
Multiple Myeloma
1,231 trials monitored
See 77 trials at risk
and 1 more disease
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov