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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05556720
Registration number
NCT05556720
Ethics application status
Date submitted
23/08/2022
Date registered
27/09/2022
Titles & IDs
Public title
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
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Scientific title
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
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Secondary ID [1]
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122.22
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV
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Organ Transplantation
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Lymphoma, Non-Hodgkin
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Chronic Lymphocytic Leukemia
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Multiple Myeloma
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COVID-19 Vaccines
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pfizer Bivalent COVID-19 Vaccine
Treatment: Other - Moderna Bivalent mRNA vaccine
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
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
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
Treatment: Other: Pfizer Bivalent COVID-19 Vaccine
One or Two doses three months apart, per manufacturer's recommendations.
Treatment: Other: Moderna Bivalent mRNA vaccine
One or Two doses three months apart, per manufacturer's recommendations.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2
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Assessment method [1]
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geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG (AU/ml)
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Timepoint [1]
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28 days after completion of trial vaccine/s
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Secondary outcome [1]
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anti-Spike IgG antibody geometric mean concentration
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Assessment method [1]
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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
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Timepoint [1]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [2]
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Seroconversion
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Assessment method [2]
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The proportion of participants seronegative to SARS-CoV-2 IgG becoming seropositive 1-, 6- and 12-months after completion of trial vaccine/s
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Timepoint [2]
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1-, 6- and 12-months after completion of trial vaccine/s
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Secondary outcome [3]
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Neutralisation responses
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Assessment method [3]
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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
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Timepoint [3]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [4]
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T cell polyfunctionality
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [5]
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T lymphocyte responses
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Assessment method [5]
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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
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Timepoint [5]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [6]
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Early local and systemic reactions
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 7 days post completion of trial vaccine/s
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Secondary outcome [7]
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Adverse Events Following Immunisation
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Assessment method [7]
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Proportion with solicited and unsolicited adverse events following immunisation (AEFI) up to Day 28.
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Timepoint [7]
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Up to 28 days post completion of trial vaccine/s
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Secondary outcome [8]
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Hospitalisation due to Immunisation
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Assessment method [8]
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Proportion of participants with hospitalisation resulting from adverse events following immunisation (AEFI) up to Day 28.
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Timepoint [8]
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Up to 28 days post completion of trial vaccine/s
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Secondary outcome [9]
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Clinical outcomes - COVID-19 infection
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Assessment method [9]
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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
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Timepoint [9]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [10]
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Clinical outcomes - Healthcare Attendance Due to COVID-19 infection
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Assessment method [10]
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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
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Timepoint [10]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [11]
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Clinical outcomes - All Cause and SARS-CoV-2 Related Mortality
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Assessment method [11]
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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
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Timepoint [11]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [12]
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Clinical outcomes - Severity
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Assessment method [12]
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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
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Timepoint [12]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [13]
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Clinical outcomes - Severe COVID-19
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Assessment method [13]
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Proportion of Participants with need for ICU care due to SARS-CoV-2 infection up to 12-months post completion of trial vaccine/s
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Timepoint [13]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [14]
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Clinical outcomes - Quality of Life
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Assessment method [14]
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Quality of life estimates (using EQ-5D-5L survey) at 1-, 6- and 12-months post completion of trial vaccine/s
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Timepoint [14]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [15]
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Clinical outcomes - Healthcare utilisation
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Assessment method [15]
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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
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Timepoint [15]
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Up to 12 months post completion of trial vaccine/s
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Secondary outcome [16]
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Clinical outcomes - All cause healthcare utilisation
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Assessment method [16]
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Proportion of participants with healthcare utilisation including outpatient pharmaceutical and medical service use and inpatient hospital admissions
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Timepoint [16]
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Up to 12 months post completion of trial vaccine/s
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Eligibility
Key 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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
960
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05556720
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James H McMahon, MBBS PhD
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Address
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Alfred Hospital, Melbourne, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Michelle Hagenauer
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Address
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Country
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Phone
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+61 3 9076 3189
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05556720