Share

Save

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

PHASE3RECRUITING

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.

info
Simpliy with AI

Study details:

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. However, data are heterogeneous, in part due the variable nature of immunodeficiencies in IC groups and non-standardised outcome measures used in studies.

BOOST-IC is an adaptive randomised clinical trial (RCT) to assess the immunogenicity and safety of additional bivalent 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. To do this, participants who have previously completed 3- to 6-doses of Australian TGA approved COVID-19 vaccines (BA.

4/5 Moderna and Pfizer vaccines) will be randomised 1:1 to receive either one or two doses of a bivalent COVID-19 vaccine, as these become available in Australia. And additional arm can be added if an additional suitable vaccine becomes available. Namely, patients will be randomised to receive either one or two doses of bivalent Moderna or Pfizer COVID-19 vaccine.

As additional bivalent vaccines become available in Australia, these will be included in the trial, as additional arms. The trial can incorporate up to three arms at one time. Patients will be followed up for 455 days post randomisation.

Specific study questions pertain to:. * examining how additional doses of COVID-19 vaccine/s affect correlates of protective immunity. * examining the safety of additional doses of COVID-19 vaccine/s.

* characterising the humoral and cellular immune responses to COVID-19 vaccination receiving 1 or 2 booster doses of COVID-19 vaccine/s.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
    • info
    Simplify with AI

    Eligibility

    Age eligible for study : 16 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-12-01

    Primary completion: 2024-02-28

    Study completion finish: 2025-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT05556720

    Intervention or treatment

    BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine

    BIOLOGICAL: Moderna Bivalent mRNA vaccine

    Conditions

    • • HIV
    • • Organ Transplantation
    • • Lymphoma, Non-Hodgkin
    • • Chronic Lymphocytic Leukemia
    • • Multiple Myeloma
    • • COVID-19 Vaccines
    Image related to HIV

    • Condition: HIV, Organ Transplantation and more

    • BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine and other drugs

    • Melbourne, Victoria, Australia

    • Sponsor: Bayside Health

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Alfred Health

    Research sites nearby

    Select from list below to view details:

    • Alfred Health

      Melbourne, Victoria, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: People living with Human Immunodeficiency Virus (HIV)
    • Eligible participants living with HIV will be randomised 1:1:1 to receive a one or two doses of bivalent COVID-19 vaccine:
    • 1. Moderna bivalent COVID-19 vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran); 25 micrograms of imelasomeran that targets the Omicron variant BA.4-5, and 25 micrograms of elasomeran that targets the ancestral strain of SARSCoV-2.
    • 2. Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
    • 3. TBC
    BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
    • One or Two doses three months apart, per manufacturer's recommendations.
    EXPERIMENTAL: Solid Organ Transplant recipients
    • Eligible participants who have previously received at least one solid organ transplant, including kidney, pancreas, liver, heart, lung, or any combination of these organs at least 6 weeks prior and without episodes of severe rejection requiring T- or B-cell depleting agents in the prior 3 months, will be randomised 1:1:1 to receive a one or two doses of bivalent COVID-19 vaccine:
    • 1. Moderna bivalent COVID-19 vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran); 25 micrograms of imelasomeran that targets the Omicron variant BA.4-5, and 25 micrograms of elasomeran that targets the ancestral strain of SARSCoV-2.
    • 2. Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
    • 3. TBC
    BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
    • One or Two doses three months apart, per manufacturer's recommendations.
    EXPERIMENTAL: People with Haematological Neoplasms (CLL, NHL, MM)
    • Undergoing chemotherapy, immunotherapy and/or targeted therapy, or completed in the last 2 years for chronic lymphocytic leukemia, multiple myeloma or non-Hodgkin lymphoma will be randomised 1:1:1 to receive a one or two doses of bivalent COVID-19 vaccine:
    • 1. Moderna bivalent COVID-19 vaccine, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran); 25 micrograms of imelasomeran that targets the Omicron variant BA.4-5, and 25 micrograms of elasomeran that targets the ancestral strain of SARSCoV-2.
    • 2. Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
    • 3. TBC
    BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
    • One or Two doses three months apart, per manufacturer's recommendations.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG (AU/ml)28 days after completion of trial vaccine/s

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    anti-Spike IgG antibody geometric mean concentrationThe geometric mean concentration (GMC) (AU/ml) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2 6- and 12-months after completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    SeroconversionThe proportion of participants seronegative to SARS-CoV-2 IgG becoming seropositive 1-, 6- and 12-months after completion of trial vaccine/s1-, 6- and 12-months after completion of trial vaccine/s
    Neutralisation responsesProportion of participants with SARS-CoV-2 neutralising antibody response in each group after 1-, 6- and 12-months post completion of trial vaccine/s, with response defined as either 4-fold rise in the neutralising antibody titre for those with detectable neutralising antibodies at baseline, OR Detectable neutralisation in those with no detectable neutralising antibodies at baselineUp to 12 months post completion of trial vaccine/s
    T cell polyfunctionalitySubset analysis and polyfunctionality (number, and concentration of effector cytokines) of SARS-CoV-2 specific T-cell responses at 1-, 6- and 12-months post completion of trial vaccine/s in a subset of participants.Up to 12 months post completion of trial vaccine/s
    T lymphocyte responsesMagnitude of SARS-CoV-2 specific T-cell responses at 1-, 6- and 12-months post completion of trial vaccine/s in a subset of participantsUp to 12 months post completion of trial vaccine/s
    Early local and systemic reactionsLocal and systemic reactions assessed by questionnaire on Day 1,2,3,4,5,6 and 7 after randomisation. Solicited and unsolicited adverse events following immunisation (AEFI) up to Day 28. Hospitalisation resulting from adverse events following immunisation (AEFI) up to Day 28.Up to 7 days post completion of trial vaccine/s
    Adverse Events Following ImmunisationProportion with solicited and unsolicited adverse events following immunisation (AEFI) up to Day 28.Up to 28 days post completion of trial vaccine/s
    Hospitalisation due to ImmunisationProportion of participants with hospitalisation resulting from adverse events following immunisation (AEFI) up to Day 28.Up to 28 days post completion of trial vaccine/s
    Clinical outcomes - COVID-19 infectionProportion of patients with PCR-confirmed OR rapid antigen test (RAT) positive SARS-CoV-2 infection in participants up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - Healthcare Attendance Due to COVID-19 infectionProportion of participants with PCR-confirmed OR rapid antigen test (RAT) positive SARS-CoV-2 infection requiring attendance at a medical facility for assessment and/or hospital admission up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - All Cause and SARS-CoV-2 Related MortalityProportion of participants experiencing mortality due to i) any cause and ii) SARS-CoV-2 infection up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - SeverityProportion of participants needing oxygen therapy and/or ventilatory support due to SARS-CoV-2 infection up to 12-months post completion of trial vaccine/s Need for ICU care due to SARS-CoV-2 infection up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - Severe COVID-19Proportion of Participants with need for ICU care due to SARS-CoV-2 infection up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - Quality of LifeQuality of life estimates (using EQ-5D-5L survey) at 1-, 6- and 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - Healthcare utilisationProportion of participants with healthcare utilisation including outpatient pharmaceutical and medical service use and inpatient hospital admissions related to COVID-19 or study vaccines up to 12-months post completion of trial vaccine/sUp to 12 months post completion of trial vaccine/s
    Clinical outcomes - All cause healthcare utilisationProportion of participants with healthcare utilisation including outpatient pharmaceutical and medical service use and inpatient hospital admissionsUp to 12 months post completion of trial vaccine/s

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

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

    Other trails to consider

    Top searched conditions

    ABN: 29 640 485 105 © 2025 Clinrol