A Prospective Multi-Site Observational Study of SARS-CoV-2 Vaccination Immunogenicity in Patients With Hematologic Malignancies
- Start Year
- 2021
- End Year
- 2023
Visit VIP
| Investigators | Contacts |
|---|---|
|
|
Design
- Study design
- Cohort
- Follow Up
- Participants are followed up 90, 180, 270, and 360 days after their second COVID-19 vaccine and 28 days after any COVID-19 vaccination dose.
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 1,404
- Number of Participants with Biological Samples
- 1,404
- Supplementary Information
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with lymphoma.
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
-
Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Participants are included if they were never treated for lymphoma, previously treated with anti-CD20 (>1 month since last treatment dose), currently receiving anti-CD20 treatment, or if they are receiving non-antiCD20 treatment (<1 month since last treatment dose).
- Supplementary Information about selection criteria
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 378
- Number of Participants with Biological Samples
- 378
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - Lymphoma patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. | 2021-08 | |
| 1 |
VIP - Lymphoma patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - Lymphoma patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - Lymphoma patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - Lymphoma patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - Lymphoma patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - Lymphoma patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with plasma cell disorders and are also included if they have untreated monoclonal gammopathy of undetermined significance or smouldering myeloma.
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
-
Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Participants are included if they are on active monotherapy with immunomodulators (IMID) or proteosome inhibitors (PI), on combination anti-CD38 plus PI therapy or combination anti-CD38 plus IMID therapy, or any other therapy.
- Supplementary Information about selection criteria
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 378
- Number of Participants with Biological Samples
- 378
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - PCD patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. | 2021-08 | |
| 1 |
VIP - PCD patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - PCD patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - PCD patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - PCD patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - PCD patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - PCD patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or myeloproliferative syndrome (and undergoing cytoreductive therapy).
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
- Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - MCAL patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. |
2021-08 | |
| 1 |
VIP - MCAL patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - MCAL patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - MCAL patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - MCAL patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - MCAL patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - MCAL patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with hematologic malignancy.
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
-
Participants are or were receiving immune effector cell-based therapy such as bi-specific T-cell engagers or chimeric antigen receptor T-cells. Therapy type must elligible for COVID-19 vaccination.
Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 54
- Number of Participants with Biological Samples
- 54
- Supplementary Information about selection criteria
- Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - IECBT patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. | 2021-08 | |
| 1 |
VIP - IECBT patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - IECBT patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - IECBT patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - IECBT patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - IECBT patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - IECBT patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with hematologic malignancy.
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
-
Participants are included if it has been at least 3 months since they have received an autologous hematopoietic stem cell transplant from the time of enrollment.
Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 162
- Number of Participants with Biological Samples
- 162
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - autoSCT patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. | 2021-08 | |
| 1 |
VIP - autoSCT patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - autoSCT patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - autoSCT patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - autoSCT patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - autoSCT patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - autoSCT patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- Ethnic Origin
-
- Health Status
-
Participants are diagnosed with hematologic malignancy. Patients with Chronic Grade II-IV graft-versus-host-disease may only be included if they are elligible for vaccination.
Participants are excluded if they have chronic myelogenous leukemia, myeloproliferative neoplasm not on cytoreductive therapy, or any absolute contraindications to the COVID-19 vaccine.
- Other Criteria
-
Participants are included if it has been at least 3 months since they have received an allogeneic hematopoietic stem cell transplant from the time of enrollment.
Participants are excluded if they received an autologous stem cell transplantation (autoSCT) or allogeneic hematopoietic stem cell transplantation (alloSCT) treatment for non-hematologic malignancy diseases.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Number of Participants
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VIP - alloSCT patients - Baseline
|
Information is collected about demographics, COVID-19 exposure risks, and history of COVID-19 infection. Blood samples are collected. | 2021-08 | |
| 1 |
VIP - alloSCT patients - Follow-up 90 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 2 |
VIP - alloSCT patients - Follow-up 180 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-11 | |
| 3 |
VIP - alloSCT patients - Follow-up 270 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-02 | |
| 4 |
VIP - alloSCT patients - Follow-up 360 days post-dose 2
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2022-05 | |
| 5 |
VIP - alloSCT patients - 28 days after any COVID-19 vaccination
|
Information is collected about potential COVID-19 exposures, COVID-19 infections, and changes in medical history. Blood samples are collected. | 2021-08 | |
| 6 |
VIP - alloSCT patients - Final collection timepoint
|
Blood samples are collected. | 2023-03 | 2023-03 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
Socio-demographic and economic characteristics
Lifestyle and behaviours
Birth, pregnancy and reproductive health history
Diseases
Symptoms and signs
Medication and supplements
Non-pharmacological interventions
Health and community care services utilization
Death
Physical measures and assessments
Laboratory measures
Cognition, personality and psychological measures and assessments
Life events, life plans, beliefs and values
Preschool, school and work life
Social environment and relationships
Physical environment
Administrative information
Psychological distress and emotions