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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
Date last updated
1/06/2023

Titles & IDs
Public title
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
Scientific title
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
Secondary ID [1] 0 0
122.22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Organ Transplantation 0 0
Lymphoma, Non-Hodgkin 0 0
Chronic Lymphocytic Leukemia 0 0
Multiple Myeloma 0 0
COVID-19 Vaccines 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2
Timepoint [1] 0 0
28 days after completion of trial vaccine/s
Secondary outcome [1] 0 0
anti-Spike IgG antibody geometric mean concentration
Timepoint [1] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [2] 0 0
Seroconversion
Timepoint [2] 0 0
1-, 6- and 12-months after completion of trial vaccine/s
Secondary outcome [3] 0 0
Neutralisation responses
Timepoint [3] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [4] 0 0
T cell polyfunctionality
Timepoint [4] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [5] 0 0
T lymphocyte responses
Timepoint [5] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [6] 0 0
Early local and systemic reactions
Timepoint [6] 0 0
Up to 7 days post completion of trial vaccine/s
Secondary outcome [7] 0 0
Adverse Events Following Immunisation
Timepoint [7] 0 0
Up to 28 days post completion of trial vaccine/s
Secondary outcome [8] 0 0
Hospitalisation due to Immunisation
Timepoint [8] 0 0
Up to 28 days post completion of trial vaccine/s
Secondary outcome [9] 0 0
Clinical outcomes - COVID-19 infection
Timepoint [9] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [10] 0 0
Clinical outcomes - Healthcare Attendance Due to COVID-19 infection
Timepoint [10] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [11] 0 0
Clinical outcomes - All Cause and SARS-CoV-2 Related Mortality
Timepoint [11] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [12] 0 0
Clinical outcomes - Severity
Timepoint [12] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [13] 0 0
Clinical outcomes - Severe COVID-19
Timepoint [13] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [14] 0 0
Clinical outcomes - Quality of Life
Timepoint [14] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [15] 0 0
Clinical outcomes - Healthcare utilisation
Timepoint [15] 0 0
Up to 12 months post completion of trial vaccine/s
Secondary outcome [16] 0 0
Clinical outcomes - All cause healthcare utilisation
Timepoint [16] 0 0
Up to 12 months post completion of trial vaccine/s

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
960
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05556720
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James H McMahon, MBBS PhD
Address 0 0
Alfred Hospital, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Hagenauer
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 3189
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05556720