HIVPhase 3BOOST-ICNCT05556720
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
A Phase 3 study testing Pfizer Bivalent COVID-19 Vaccine and Moderna Bivalent mRNA vaccine in people with HIV and Organ Transplantation, run by Monash University at 13 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV, Organ Transplantation, Lymphoma, Non-Hodgkin
- What is being tested?
- Pfizer Bivalent COVID-19 Vaccine and Moderna Bivalent mRNA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 13 sitesAustralia
- Study dates
- 1 Dec 2022to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to give informed consent and undertake study procedures
- Age ≥16 years old
- Have completed at least 3 months prior, 3- to 8-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.
Who cannot join
- 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 less than 3 or more than 8 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
Show all 9Show fewer
- 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
- Have not received another licensed vaccine in the 7 days before or 7 days after the day of receiving the COVID-19 study vaccine (NOTE: Participants can receive another licensed vaccine on the same day as the COVID-19 vaccine)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Medical Centre
Clayton, Victoria, 3168
St Vincents Hospital
Darlinghurst, New South Wales
St Vincents Hospital
Fitzroy, Victoria, 3065
University Geelong Hospital
Geelong, Victoria, 3220
Austin Hospital
Heidelberg, Victoria, 3084
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Royal Melbourne Hospital
Melbourne, Victoria, 3000
Alfred Health
Melbourne, Victoria, 3004
Prince Of Wales Hospital
Randwick, New South Wales, 2031
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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.
Read the detailed description
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 8-doses of Australian TGA approved COVID-19 vaccines (Moderna and Pfizer vaccines) will be randomised 1:1 to receive either one or two doses of the current TGA approved COVID-19 vaccine. .An 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 Moderna or Pfizer COVID-19 vaccine. As additional COVID-19 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
- Conditions
- HIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Multiple Myeloma, COVID-19 Vaccines
- Being tested
- Pfizer Bivalent COVID-19 Vaccine, Moderna Bivalent mRNA vaccine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfizer Bivalent COVID-19 VaccineBiological
Also called Pfizer-BioNTech bivalent mRNA vaccine, COMIRNATY Original/Omicron BA.1
One or Two doses three months apart, per manufacturer's recommendations.
Moderna Bivalent mRNA vaccineBiological
Also called Moderna Bivalent Original/Omicron, Elasomeran/imelasomeran, Spikevax
One or Two doses three months apart, per manufacturer's recommendations.
| Study group | Role | What they receive |
|---|---|---|
| People living with Human Immunodeficiency Virus (HIV) | Experimental | Eligible participants living with HIV will be randomised 1:1:1 to receive a one or two doses of either current TGA approved COVID-19 vaccines
1. Moderna COVID-19 vaccine, SPIKEVAX XBB1.5 Adult dose of Spikevax XBB.1.5 contains 50 micrograms of messenger ribonucleic acid (mRNA) (Andusomeran) that encodes the spike protein of the XBB.1.5 strain of the virus.
2. PfizerCOVID-19 vaccine, COMIRNATYOMICRONXBB.1.5 Adult dose of Comirnaty Omicron XBB.1.5 contains 30 micrograms of a single-stranded, 5'-capped messenger RNA (mRNA) (Raxtozinameran) which encodes the spike protein of the XBB.1.5 strain of the virus. Receives: Biological: Pfizer Bivalent COVID-19 Vaccine; Biological: Moderna Bivalent mRNA vaccine |
| Solid Organ Transplant recipients | Experimental | 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 Receives: Biological: Pfizer Bivalent COVID-19 Vaccine; Biological: Moderna Bivalent mRNA vaccine |
| People with Haematological Neoplasms (CLL, NHL, MM) | Experimental | 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 Receives: Biological: Pfizer Bivalent COVID-19 Vaccine; Biological: Moderna Bivalent mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days after completion of trial vaccine/s
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 months post completion of trial vaccine/s
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Dec 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants who have received three to eight doses of Australian TGA approved COVID-19 vaccine will be randomised into one of up to three groups. They will be administered either one or two homologous doses of COVID-19 vaccines, e.g. Moderna mRNA vaccine OR Pfizer mRNA vaccine, using a central computer-generated random allocation algorithm, with random block sizes of 3 or 6. Randomisation will be stratified by: \- Study subgroup (HIV, solid organ transplant, haematological malignancy)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, University of Melbourne
- Responsible party
- Sponsor
- Investigators
- James H McMahon, MBBS PhD, Principal investigator, Alfred Hospital, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556720
- Sponsor's protocol ID
- 122.22
- Acronym
- BOOST-IC
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dymock M, McMahon JH, Griffin D, Hagenauer M, Snelling TL, Marsh JA; On behalf of the BOOST-IC Investigator Team. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations: statistical elements and design. Trials. 2025 Jul 25;26(1):256. doi: 10.1186/s13063-025-08965-w.
PubMed 40713834Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
PubMed 40396505Griffin DWJ, Dymock M, Wong G, Morrissey CO, Lewin SR, Cheng AC, Howard K, Marsh JA, Subbarao K, Hagenauer M, Roney J, Cunningham A, Snelling T, McMahon JH. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial. Trials. 2024 Jul 17;25(1):485. doi: 10.1186/s13063-024-08315-2.
PubMed 39020446
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05556720
- Acronym / sponsor ID
- BOOST-IC / 122.22
- Conditions
- HIV, Organ Transplantation, Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia, Multiple Myeloma, COVID-19 Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- University of Sydney, University of Melbourne
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 8-doses of Australian TGA approved COVID-19 vaccines (Moderna and Pfizer vaccines) will be randomised 1:1 to receive either one or two doses of the current TGA approved COVID-19 vaccine. .An 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 Moderna or Pfizer COVID-19 vaccine. As additional COVID-19 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study participants who have received three to eight doses of Australian TGA approved COVID-19 vaccine will be randomised into one of up to three groups. They will be administered either one or two homologous doses of COVID-19 vaccines, e.g. Moderna mRNA vaccine OR Pfizer mRNA vaccine, using a central computer-generated random allocation algorithm, with random block sizes of 3 or 6. Randomisation will be stratified by: - Study subgroup (HIV, solid organ transplant, haematological malignancy)
| Arm | Type | Receives |
|---|---|---|
| People living with Human Immunodeficiency Virus (HIV) | Experimental | Biological: Pfizer Bivalent COVID-19 Vaccine, Biological: Moderna Bivalent mRNA vaccineEligible participants living with HIV will be randomised 1:1:1 to receive a one or two doses of either current TGA approved COVID-19 vaccines 1. Moderna COVID-19 vaccine, SPIKEVAX XBB1.5 Adult dose of Spikevax XBB.1.5 contains 50 micrograms of messenger ribonucleic acid (mRNA) (Andusomeran) that encodes the spike protein of the XBB.1.5 strain of the virus. 2. PfizerCOVID-19 vaccine, COMIRNATYOMICRONXBB.1.5 Adult dose of Comirnaty Omicron XBB.1.5 contains 30 micrograms of a single-stranded, 5'-capped messenger RNA (mRNA) (Raxtozinameran) which encodes the spike protein of the XBB.1.5 strain of the virus. |
| Solid Organ Transplant recipients | Experimental | Biological: Pfizer Bivalent COVID-19 Vaccine, Biological: Moderna Bivalent mRNA vaccineEligible 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 |
| People with Haematological Neoplasms (CLL, NHL, MM) | Experimental | Biological: Pfizer Bivalent COVID-19 Vaccine, Biological: Moderna Bivalent mRNA vaccineUndergoing 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Able to give informed consent and undertake study procedures
- Age ≥16 years old
- Have completed at least 3 months prior, 3- to 8-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.
Key exclusion criteria (9 listed)
- 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 less than 3 or more than 8 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pfizer Bivalent COVID-19 VaccineAlso: Pfizer-BioNTech bivalent mRNA vaccine, COMIRNATY Original/Omicron BA.1One or Two doses three months apart, per manufacturer's recommendations. | Biological | People living with Human Immunodeficiency Virus (HIV), People with Haematological Neoplasms (CLL, NHL, MM), Solid Organ Transplant recipients |
| Moderna Bivalent mRNA vaccineAlso: Moderna Bivalent Original/Omicron, Elasomeran/imelasomeran, SpikevaxOne or Two doses three months apart, per manufacturer's recommendations. | Biological | People living with Human Immunodeficiency Virus (HIV), People with Haematological Neoplasms (CLL, NHL, MM), Solid Organ Transplant recipients |
Primary outcome
The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2
Time frame: 28 days after completion of trial vaccine/s
geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG (AU/ml)
16 secondary outcomes
anti-Spike IgG antibody geometric mean concentration
Time frame: Up to 12 months post completion of trial vaccine/s
Seroconversion
Time frame: 1-, 6- and 12-months after completion of trial vaccine/s
Neutralisation responses
Time frame: Up to 12 months post completion of trial vaccine/s
T cell polyfunctionality
Time frame: Up to 12 months post completion of trial vaccine/s
T lymphocyte responses
Time frame: Up to 12 months post completion of trial vaccine/s
Early local and systemic reactions
Time frame: Up to 7 days post completion of trial vaccine/s
Adverse Events Following Immunisation
Time frame: Up to 28 days post completion of trial vaccine/s
Hospitalisation due to Immunisation
Time frame: Up to 28 days post completion of trial vaccine/s
Clinical outcomes - COVID-19 infection
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - Healthcare Attendance Due to COVID-19 infection
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - All Cause and SARS-CoV-2 Related Mortality
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - Severity
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - Severe COVID-19
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - Quality of Life
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - Healthcare utilisation
Time frame: Up to 12 months post completion of trial vaccine/s
Clinical outcomes - All cause healthcare utilisation
Time frame: Up to 12 months post completion of trial vaccine/s
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 40713834Dymock M, McMahon JH, Griffin D, Hagenauer M, Snelling TL, Marsh JA; On behalf of the BOOST-IC Investigator Team. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations: statistical elements and design. Trials. 2025 Jul 25;26(1):256. doi: 10.1186/s13063-025-08965-w.
- Derived from this study: PubMed 40396505Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
- Derived from this study: PubMed 39020446Griffin DWJ, Dymock M, Wong G, Morrissey CO, Lewin SR, Cheng AC, Howard K, Marsh JA, Subbarao K, Hagenauer M, Roney J, Cunningham A, Snelling T, McMahon JH. Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial. Trials. 2024 Jul 17;25(1):485. doi: 10.1186/s13063-024-08315-2.
- Individual participant dataSharing planned: No
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People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James H McMahon, MBBS PhD principal investigator
Alfred Hospital, Melbourne, Australia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pfizer Bivalent COVID-19 Vaccine and Moderna Bivalent mRNA vaccine in people with HIV and Organ Transplantation, run by Monash University at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2 (time frame: 28 days after completion of trial vaccine/s). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556720, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.