Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000538842
Ethics application status
Approved
Date submitted
6/04/2021
Date registered
6/05/2021
Date last updated
6/05/2021
Date data sharing statement initially provided
6/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
COVID-19 Vaccine Efficacy in patients with Blood Cancer
Scientific title
COVID-19 Vaccine Efficacy in patients with Haematological Malignancy
Secondary ID [1] 303823 0
None
Universal Trial Number (UTN)
Trial acronym
COVEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological Malignancy
 321343 0
Bone Marrow Transplant 321344 0
COVID-19 321345 0
Condition category
Condition code
Cancer 319121 319121 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 319122 319122 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 319123 319123 0 0
Myeloma
Cancer 319124 319124 0 0
Hodgkin's
Cancer 319125 319125 0 0
Leukaemia - Acute leukaemia
Cancer 319126 319126 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Immune responses to COVID-19 vaccination.
Five blood samples will be collected from one week prior to first vaccination until six months after the second vaccination dose. Specifically the samples are collected at the following timepoints;
1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose)
2) 72 hours prior to or after 2ndCOVID-19 vaccination dose
3) 14-18 days (+/- 2 days) after 2ndCOVID-19 vaccination dose
4) 4-6 weeks (+/- 1 week) after 2ndCOVID-19 vaccination dose
5) 6 months (+/- 2 weeks) after 2ndCOVID-19 vaccination dose
Medical information regarding diagnosis and treatment will also be collected, and will include inquiring about any subsequent COVID-19 infection for 12 months after the second vaccination.
30 patients who have received treatment with B cell depleting therapies or bone marrow transplantation will be recruited from within cancer care populations and a control group of 20 patients without a cancer diagnosis or treatment will also be recruited.
Intervention code [1] 320190 0
Not applicable
Comparator / control treatment
Participants will be patients 18 years and older who are planned to be vaccinated against COVID-19.
Control group
Active

Outcomes
Primary outcome [1] 327095 0
To characterise humoral responses to SARS-CoV-2 vaccination in patients with blood cancers treated with B cell targeted therapies and bone marrow transplantation.
Timepoint [1] 327095 0
Final blood sample collection occurs 6 months after final COVID-19 vaccination.
The collection schedule for all samples is as follows;
1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose)
2) 72 hours prior to or after 2nd COVID-19 vaccination dose
3) 14-18 days (+\- 2 days) after 2nd COVID-19 vaccination dose
4) 4-6 weeks (+\- 1 week) after 2nd COVID-19 vaccination dose
5) 6 months (+\- 2 weeks) after 2nd COVID-19 vaccination dose
Primary outcome [2] 327369 0
To characterise cellular responses to SARS-CoV-2 vaccination in patients who have received treatments for haematological malignancies targeting specific immune cells, B Cells, and those who have undergone bone marrow transplantation. A group of healthy controls will also be included for comparison.
Timepoint [2] 327369 0
Final blood sample collection occurs 6 months after final COVID-19 vaccination.
The collection schedule for all samples is as follows;
1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose)
2) 72 hours prior to or after 2nd COVID-19 vaccination dose
3) 14-18 days (+\- 2 days) after 2nd COVID-19 vaccination dose
4) 4-6 weeks (+\- 1 week) after 2nd COVID-19 vaccination dose
5) 6 months (+\- 2 weeks) after 2nd COVID-19 vaccination dose
Secondary outcome [1] 393769 0
To record subsequent COVID-19 infection rates after vaccine administration. Data will be collected from participants during the 12 month follow-up period.
Timepoint [1] 393769 0
Information regarding clinical outcomes will be collected until 12 months after second COVID-19 vaccination dose.

Eligibility
Key inclusion criteria
1. Greater than or equal to 18 years of age
2. Able to provide voluntary informed consent
3. Planned receipt of a COVID19 vaccine of any variety; e.g. Pfizer-BioNTech BNT162b2, AstraZeneca Oxford ChAdOx1 nCoV-19 (AZD1222), Novavax NVX-CoV2373 or ModernaTX mRNA-1273 vaccine.
- Patients who have any haematological malignancy and received treatment with a B-cell targeted therapy or who have received a bone marrow transplant may be recruited to Cohort A.
- Patients who do not have a diagnosis of a haematological malignancy or any other active cancer, and who have not received treatment with B cell depleting antibodies will be recruited to Cohort B. 50 patients will be recruited in total, 30 to Cohort A and 20 to Cohort B.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current diagnosis of and/or treatment for a non-haematological malignancy.
2. Receipt of B cell targeted therapies for Rheumatological or other non-haematological malignancy indication
3. Unable to provide voluntary informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Immunological assays including measurement of COVID-19 specific antibodies, serum cytokines and cellular enumeration and immunophenotyping will be performed. Immunological assays will be correlated with clinical information regarding type of cancer treatment delivered and baseline clinical characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
6/04/2022
Actual
Date of last data collection
Anticipated
6/07/2023
Actual
Sample size
Target
50
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19059 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 33609 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308220 0
Charities/Societies/Foundations
Name [1] 308220 0
QIMR Berghofer Medical Research Institute COVID-19 Research Fund
Country [1] 308220 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 309074 0
None
Name [1] 309074 0
Address [1] 309074 0
Country [1] 309074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308202 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 308202 0
Lower ground floor, Executive Offices
James Mayne Building
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 308202 0
Australia
Date submitted for ethics approval [1] 308202 0
23/02/2021
Approval date [1] 308202 0
04/03/2021
Ethics approval number [1] 308202 0
73535

Summary
Brief summary
This study will investigate immune responses to vaccination in patients with blood cancer who have received treatments targeting specific immune cells, B cells, those who have undergone bone marrow transplantation and a group of healthy volunteers who have not been treated for blood cancer or received any immune cell treatments.

Who is it for?
You may be eligible for this study if you are aged 18 or older, have been diagnosed with a blood cancer (including non Hodgkin's lymphoma, myeloma, Hodgkin's and leukemia) and have received either treatment with a B-cell targeted therapy or received a bone marrow transplant, and you are planning to have a COVID-19 vaccine of any variety. A second group of adults aged 18 and older who do not have a diagnosis of blood cancer or any other active cancer, who have not received treatment with B cell depleting antibodies, and who are also planning to have a COVID-19 vaccine of any variety will also be recruited.

Study details
Participants who choose to enrol in this study will be asked to provide up to five blood samples, starting up to 1 week beforethe first COVID-19 vaccine dose and continuing until 6 months after the second COVID-19 vaccine dose has been administered. We will also ask to review your medical records over the 12 months after you have received the second dose and may contact you to confirm any positive COVID-19 test results.

It is hoped this research will enable researchers to understand how these cancer treatments affect the immune response to COVID-19 vaccination and whether vaccination will provide effective protection in patients with blood cancers.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 109910 0
Dr Andrea Henden
Address 109910 0
QIMR Berghofer Medical Research Institute
300 Herston Road
HERSTON QLD 4006
and
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 109910 0
Australia
Phone 109910 0
+61 7 3845 3968
Fax 109910 0
N/A
Email 109910 0
[email protected]
Contact person for public queries
Name 109911 0
Dr Andrea Henden
Address 109911 0
QIMR Berghofer Medical Research Institute
300 Herston Road
HERSTON QLD 4006
and
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 109911 0
Australia
Phone 109911 0
+61 7 3845 3968
Fax 109911 0
N/A
Email 109911 0
[email protected]
Contact person for scientific queries
Name 109912 0
Dr Andrea Henden
Address 109912 0
QIMR Berghofer Medical Research Institute
300 Herston Road
HERSTON QLD 4006
and
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 109912 0
Australia
Phone 109912 0
+61 7 3845 3968
Fax 109912 0
N/A
Email 109912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.