Trial Title:
Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
NCT ID:
NCT05556720
Condition:
HIV
Organ Transplantation
Lymphoma, Non-Hodgkin
Chronic Lymphocytic Leukemia
Multiple Myeloma
COVID-19 Vaccines
Conditions: Official terms:
COVID-19
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Vaccines
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Study participants who have received three to six doses of Australian TGA approved
COVID-19 vaccine will be randomised into one of up to three groups, who will be
administered either one or two homologous doses of bivalent COVID-19 vaccines, e.g.
bivalent Moderna mRNA vaccine OR bivalent 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)
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Both study participants and investigators will be blinded to treatment allocation.
Individual assignments will be delivered securely and confidentially to the identified
site personnel administering the vaccines via a web-based portal.
Intervention:
Intervention type:
Biological
Intervention name:
Pfizer Bivalent COVID-19 Vaccine
Description:
One or Two doses three months apart, per manufacturer's recommendations.
Arm group label:
People living with Human Immunodeficiency Virus (HIV)
Arm group label:
People with Haematological Neoplasms (CLL, NHL, MM)
Arm group label:
Solid Organ Transplant recipients
Other name:
Pfizer-BioNTech bivalent mRNA vaccine
Other name:
COMIRNATY Original/Omicron BA.1
Intervention type:
Biological
Intervention name:
Moderna Bivalent mRNA vaccine
Description:
One or Two doses three months apart, per manufacturer's recommendations.
Arm group label:
People living with Human Immunodeficiency Virus (HIV)
Arm group label:
People with Haematological Neoplasms (CLL, NHL, MM)
Arm group label:
Solid Organ Transplant recipients
Other name:
Moderna Bivalent Original/Omicron
Other name:
Elasomeran/imelasomeran
Other name:
Spikevax
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.
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 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
Criteria for eligibility:
Criteria:
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.
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Michelle Hagenauer
Phone:
+613 9076 3189
Email:
m.hagenauer@alfred.org.au
Investigator:
Last name:
James H McMahon, MBBS PhD
Email:
Principal Investigator
Start date:
December 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Bayside Health
Agency class:
Other
Collaborator:
Agency:
Monash University
Agency class:
Other
Source:
Bayside Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556720
