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

Launched by BAYSIDE HEALTH · Sep 25, 2022

Keywords

ClinConnect Summary

The BOOST-IC clinical trial is studying the safety and effectiveness of additional COVID-19 vaccine doses for people with weakened immune systems. This includes individuals living with HIV, those who have received organ transplants, and patients undergoing treatment for certain types of blood cancers. The goal is to better understand how these extra doses can help protect these vulnerable populations against COVID-19, especially since they may not respond as well to the vaccines as others.

To participate in this trial, individuals must be at least 16 years old and have received between 3 to 6 doses of an approved COVID-19 vaccine at least three months prior. They should also be part of one of the specified groups, such as being HIV positive or a recent organ transplant recipient. Participants will receive additional vaccine doses and will be monitored for their immune response and any potential side effects. It's important to note that some individuals may not be eligible, such as those with certain health conditions or who are currently involved in other vaccine trials. If you or a loved one fits the criteria, this study could provide valuable information to improve COVID-19 protection for immunocompromised individuals.

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Eligibility 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