Optimizing COVID-19 vaccine schedules for immunocompromised individuals
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
PHASE3 · Bayside Health · NCT05556720
This study is testing whether giving extra doses of a COVID-19 vaccine helps people with weakened immune systems, like those with HIV or who have had organ transplants, to build better protection against the virus.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 960 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Bayside Health (other gov) |
| Drugs / interventions | CAR T, chemotherapy, immunotherapy |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT05556720 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of additional COVID-19 vaccine doses in immunocompromised individuals, including those with HIV, organ transplant recipients, and patients with certain blood cancers. Participants who have previously received 3 to 6 doses of approved COVID-19 vaccines will be randomly assigned to receive either one or two doses of a bivalent COVID-19 vaccine. The study aims to generate high-quality evidence on the immunogenicity of these booster strategies specifically for immunocompromised populations in Australia.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 and older who are immunocompromised due to HIV, solid organ transplants, or specific hematological malignancies.
Not a fit: Patients who are contraindicated to receive a COVID-19 booster vaccination or who have not completed the required number of prior vaccine doses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance COVID-19 vaccine efficacy and safety for immunocompromised patients, potentially reducing their risk of severe illness.
How similar studies have performed: Other studies have explored COVID-19 vaccination in immunocompromised populations, but this trial aims to provide more targeted evidence on booster strategies, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to give informed consent and undertake study procedures * Age ≥16 years old * Have completed at least 3 months prior, 3- to 6-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. Exclusion Criteria: * 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. * Has had led less than 3 or more than 6 doses of COVID-19 vaccine * Is on another clinical trial investigating alternate COVID-19 vaccination schedules or investigational drugs to prevent or treat COVID-19 * Life expectancy \< 12 months, or enrolment deemed not in the best interest of the patient * Unable to provide informed consent * 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
Where this trial is running
Melbourne, Victoria
- Alfred Health — Melbourne, Victoria, Australia (RECRUITING)
Study contacts
- Principal investigator: James H McMahon, MBBS PhD — Alfred Hospital, Melbourne, Australia
- Study coordinator: Michelle Hagenauer
- Email: m.hagenauer@alfred.org.au
- Phone: +61 3 9076 3189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Multiple Myeloma, COVID-19 Vaccines