NCT05556720Active, not recruitingPhase 3
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 960 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Monash University
- NCT number
- NCT05556720
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 960
- From 1 Dec 2022 to the primary completion date, 30 Jun 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are contraindicated to receive a COVID-19 booster vaccination, e.g. history of anaphylaxis to a vaccine component or myocarditis attributed to previous receipt of an mRNA vaccine.
- Is on another clinical trial investigating alternate COVID-19 vaccination schedules or investigational drugs to prevent or treat COVID-19
- Receipt of SARS-CoV-2 specific monoclonal antibodies in the 3 months prior to receiving the first dose of study vaccine
- Acute respiratory tract infection and/or temperature \> 38 degrees centigrade on day of receiving first dose of study vaccine
- History of autologous stem cell transplant in the prior 6 months or history of ever having an allogeneic stem cell transplant or CAR T-cell therapy
- Have not received another licensed vaccine in the 7 days before or 7 days after the day of receiving the COVID-19 study vaccine (NOTE: Participants can receive another licensed vaccine on the same day as the COVID-19 vaccine)
Other illness
- Has had less than 3 or more than 8 doses of COVID-19 vaccine
Other
- Life expectancy \< 12 months, or enrolment deemed not in the best interest of the patient
- Unable to provide informed consent
Who the study is looking for
- Able to give informed consent and undertake study procedures
- Age ≥16 years old
- Have completed at least 3 months prior, 3- to 8-doses of an Australian TGA approved SARS-CoV-2 vaccine (including mRNA \[Pfizer or Moderna\], ChAdOx1 \[Oxford/Astra Zeneca\] or protein \[Novavax\])
- Fit the criteria to be included in one of the following 3 populations: Infected with HIV; Current recipient of a solid organ transplant including: kidney, pancreas, liver, malignancy episodes of severe rejection requiring T- or B-cell depleting agents in the prior 3 months; Undergoing chemotherapy, immunotherapy and/or targeted therapy, or completed in the last 2 years for: chronic lymphocytic leukemia, multiple myeloma or non-Hodgkin lymphoma.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| St Vincents Hospital Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St Vincents Hospital Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| University Geelong Hospital Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Royal Brisbane and Womens Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.