Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 960
- 试验地点
- 12
- 主要终点
- The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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)
研究组 & 干预措施
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 either current TGA approved COVID-19 vaccines
- 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.
- 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.
干预措施: Pfizer Bivalent COVID-19 Vaccine (Biological)
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 either current TGA approved COVID-19 vaccines
- 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.
- 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.
干预措施: Moderna Bivalent mRNA vaccine (Biological)
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:
- 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.
- Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
- TBC
干预措施: Pfizer Bivalent COVID-19 Vaccine (Biological)
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:
- 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.
- Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
- TBC
干预措施: Moderna Bivalent mRNA vaccine (Biological)
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:
- 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.
- Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
- TBC
干预措施: Pfizer Bivalent COVID-19 Vaccine (Biological)
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:
- 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.
- Pfizer bivalent COVID-19 vaccine, COMIRNATY ORIGINAL/OMICRON BA.4-5 (tozinameran/famtozinameran); 15 µg of tozinameran and 15 µg of famtozinameran.
- TBC
干预措施: Moderna Bivalent mRNA vaccine (Biological)
结局指标
主要结局
The geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG antibody against SARS-CoV-2
时间窗: 28 days after completion of trial vaccine/s
geometric mean concentration (GMC) of anti-spike SARS-CoV-2 IgG (AU/ml)
次要结局
- Clinical outcomes - Severe COVID-19(Up to 12 months post completion of trial vaccine/s)
- T cell polyfunctionality(Up to 12 months post completion of trial vaccine/s)
- Adverse Events Following Immunisation(Up to 28 days post completion of trial vaccine/s)
- anti-Spike IgG antibody geometric mean concentration(Up to 12 months post completion of trial vaccine/s)
- Hospitalisation due to Immunisation(Up to 28 days post completion of trial vaccine/s)
- Clinical outcomes - All Cause and SARS-CoV-2 Related Mortality(Up to 12 months post completion of trial vaccine/s)
- Clinical outcomes - Severity(Up to 12 months post completion of trial vaccine/s)
- Clinical outcomes - All cause healthcare utilisation(Up to 12 months post completion of trial vaccine/s)
- Seroconversion(1-, 6- and 12-months after completion of trial vaccine/s)
- T lymphocyte responses(Up to 12 months post completion of trial vaccine/s)
- Early local and systemic reactions(Up to 7 days post completion of trial vaccine/s)
- Clinical outcomes - Quality of Life(Up to 12 months post completion of trial vaccine/s)
- Neutralisation responses(Up to 12 months post completion of trial vaccine/s)
- Clinical outcomes - COVID-19 infection(Up to 12 months post completion of trial vaccine/s)
- Clinical outcomes - Healthcare Attendance Due to COVID-19 infection(Up to 12 months post completion of trial vaccine/s)
- Clinical outcomes - Healthcare utilisation(Up to 12 months post completion of trial vaccine/s)