Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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