A Prospective Multi-Site Observational Study of SARS-CoV-2 Vaccination Immunogenicity in Patients With Hematologic Malignancies
Overview
- Acronym
- VIP
- Website
- VIP
- Investigators
-
- Contacts
-
General Design
- Study design
- Cohort
- Start - End Year
- 2021 - 2023
- General Information on Follow Up (profile, frequency)
-
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 Target
-
- Individuals
- Number of Participants
- 1,404
- Number of Participants with Biological Samples
- 1,404
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Timeline
Populations
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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).
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 378
- Number of Participants with Biological Samples
- 378
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - Lymphoma patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - Lymphoma patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - Lymphoma patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - Lymphoma patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - Lymphoma patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - Lymphoma patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - Lymphoma patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 378
- Number of Participants with Biological Samples
- 378
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - PCD patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - PCD patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - PCD patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - PCD patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - PCD patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - PCD patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - PCD patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - MCAL patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - MCAL patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - MCAL patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - MCAL patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - MCAL patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - MCAL patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - MCAL patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 54
- Number of Participants with Biological Samples
- 54
- Supplementary information about number of participants
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - IECBT patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - IECBT patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - IECBT patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - IECBT patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - IECBT patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - IECBT patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - IECBT patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 162
- Number of Participants with Biological Samples
- 162
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - autoSCT patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - autoSCT patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - autoSCT patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - autoSCT patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - autoSCT patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - autoSCT patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - autoSCT patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- Ontario
- Quebec
- Territory
- Edmonton, Montreal, Ottawa, Toronto
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited in hematology clinics from one of twelve participating hospitals around Canada.
Sample Size
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VIP - alloSCT patients - Baseline |
|
|
2021 (August) | Ongoing |
| 1 | VIP - alloSCT patients - Follow-up 90 days post-dose 2 |
|
|
2021 (August) | Ongoing |
| 2 | VIP - alloSCT patients - Follow-up 180 days post-dose 2 |
|
|
2021 (November) | Ongoing |
| 3 | VIP - alloSCT patients - Follow-up 270 days post-dose 2 |
|
|
2022 (February) | Ongoing |
| 4 | VIP - alloSCT patients - Follow-up 360 days post-dose 2 |
|
|
2022 (May) | Ongoing |
| 5 | VIP - alloSCT patients - 28 days after any COVID-19 vaccination |
|
|
2021 (August) | Ongoing |
| 6 | VIP - alloSCT patients - Final collection timepoint |
|
|
2023 (March) | 2023 (March) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
Areas of Information Collected per per Population and Data Collection Event
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|