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Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE3
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
Find a site
Closest Location:
Alfred Health
Research sites nearby
Select from list below to view details:
Alfred Health
Melbourne, Victoria, Australia
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: People living with Human Immunodeficiency Virus (HIV)
| BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
|
EXPERIMENTAL: Solid Organ Transplant recipients
| BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
|
EXPERIMENTAL: People with Haematological Neoplasms (CLL, NHL, MM)
| BIOLOGICAL: Pfizer Bivalent COVID-19 Vaccine
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2 | geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG (AU/ml) | 28 days after completion of trial vaccine/s |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
anti-Spike IgG antibody geometric mean concentration | The 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/s | Up to 12 months post completion of trial vaccine/s |
Seroconversion | The proportion of participants seronegative to SARS-CoV-2 IgG becoming seropositive 1-, 6- and 12-months after completion of trial vaccine/s | 1-, 6- and 12-months after completion of trial vaccine/s |
Neutralisation responses | Proportion 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 baseline | Up to 12 months post completion of trial vaccine/s |
T cell polyfunctionality | Subset 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 responses | Magnitude 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 |
Early local and systemic reactions | Local 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 Immunisation | Proportion 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 Immunisation | Proportion 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 infection | Proportion 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/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - Healthcare Attendance Due to COVID-19 infection | Proportion 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/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - All Cause and SARS-CoV-2 Related Mortality | Proportion of participants experiencing mortality due to i) any cause and ii) SARS-CoV-2 infection up to 12-months post completion of trial vaccine/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - Severity | Proportion 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/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - Severe COVID-19 | Proportion of Participants with need for ICU care due to SARS-CoV-2 infection up to 12-months post completion of trial vaccine/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - Quality of Life | Quality of life estimates (using EQ-5D-5L survey) at 1-, 6- and 12-months post completion of trial vaccine/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - Healthcare utilisation | Proportion 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/s | Up to 12 months post completion of trial vaccine/s |
Clinical outcomes - All cause healthcare utilisation | Proportion of participants with healthcare utilisation including outpatient pharmaceutical and medical service use and inpatient hospital admissions | Up to 12 months post completion of trial vaccine/s |
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