Vaccine Immunogenicity and Safety in ImmunoDeficient Patients
The primary objective of this study is to determine SARS-CoV-2 specific humoral and cell-mediated immune responses to COVID-19 vaccination in the study patient population versus controls and subgroups versus controls.
The secondary objectives are to:
1. Estimate the frequency of adverse events following SARS-CoV-2 vaccination among the study immunodeficient patients. Specific adverse events following immunization (AEFI) of interest in this patient population are local reactions, systemic reactogenicity (e.g., fever, headache, fatigue, malaise), hypersensitivity reactions, and disease-specific safety outcomes (e.g., flare of autoimmune disease or complications of immune dysregulation including cytopenia).
2. Measure the frequency of COVID-19 infections in vaccinated immunocompromised patients.
Overview
- Acronym
- VISID
- Website
- VISID
- Investigators
-
- Contacts
-
General Design
- Study design
- Cohort
- Start - End Year
- 2021 - 2022
- General Information on Follow Up (profile, frequency)
-
The vaccine naïve participants were followed-up at first vaccination (Visit 1), 4-12 weeks after the first dose (Visit 2), 4 weeks and 24 weeks after the second dose (Follow-up 1 and 2). The vaccine experienced participants were followed up at vaccination (Visit 1), 4 and 24 weeks after the second dose (Visit 2 and 3).
- Recruitment Target
-
- Individuals
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Timeline
Populations
VISID - Vaccine naive subgroup A
The population is composed of patients who are 12 years old and older, are vaccine naive and predominant B cell defect.
These patiens have a primary antibody deficiency including but not limited to common variable immunodeficiency and x-linked agammaglobulinemia who are being treated or recently treated (< 6 months) with B-cell depleting therapy (e.g. rituximab, ocrelizumab) or with B-cell activating factor inhibitor (e.g. belimumab), including patients with immune-mediated diseases such as multiple sclerosis, rheumatoid arthritis, and granulomatous polyangiitis as well as patients with hematological malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine naive subgroup A - Baseline |
|
|
2021 (June) | Ongoing |
| 1 | VISID - Vaccine naive subgroup A - Visit 1 |
|
|
2021 (July) | Ongoing |
| 2 | VISID - Vaccine naive subgroup A - Visit 2 |
|
|
2021 (August) | Ongoing |
| 3 | VISID - Vaccine naive subgroup A - Follow-up 1 |
|
|
2021 (September) | Ongoing |
| 4 | VISID - Vaccine naive subgroup A - Follow-up 2 |
|
|
2022 (January) | Ongoing |
VISID - Vaccine naive subgroup B
The population is composed of patients who are 12 years old and older, are vaccine naive and have a combined B- and T-cell defect (Combined B-cell and T-cell immunodeficiency diagnosis).
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine naive subgroup B - Baseline |
|
|
2021 (June) | Ongoing |
| 1 | VISID - Vaccine naive subgroup B - Visit 1 |
|
|
2021 (July) | Ongoing |
| 2 | VISID - Vaccine naive subgroup B - Visit 2 |
|
|
2021 (August) | Ongoing |
| 3 | VISID - Vaccine naive subgroup B - Follow-up 1 |
|
|
2021 (September) | Ongoing |
| 4 | VISID - Vaccine naive subgroup B - Follow-up 2 |
|
|
2022 (January) | Ongoing |
VISID - Vaccine naive subgroup C
The population is composed of patients who are 12 years old and older, are vaccine naive and have another inborn error of immunity including but not limited to non-transplanted chronic granulomatous disease, complement deficiency, and presence of autoantibodies to cytokines.
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine naive subgroup C - Baseline |
|
|
2021 (June) | Ongoing |
| 1 | VISID - Vaccine naive subgroup C - Visit 1 |
|
|
2021 (July) | Ongoing |
| 2 | VISID - Vaccine naive subgroup C - Visit 2 |
|
|
2021 (August) | Ongoing |
| 3 | VISID - Vaccine naive subgroup C - Follow-up 1 |
|
|
2021 (September) | Ongoing |
| 4 | VISID - Vaccine naive subgroup C - Follow-up 2 |
|
|
2022 (January) | Ongoing |
VISID - Vaccine naive control
The population is composed of participants who are 12 years old and older, are vaccine naive and immunocompetent.
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Healthy controls will be recruited from family and friends of the patient participants, hospital administrative staff who have not been vaccinated, patients at Public Health Immunization Clinics, and previous study participants listed in the Canadian Center for Vaccinology database. We will also engage patient organizations, Public Health Units, and local media through each hospital’s Public Relation’s team to assist in the study advertisement. A study webpage will be created as an additional recruitment strategy. Interested participants can register and provide contact information for the study coordinator to proceed with consenting process.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine naive Control - Baseline |
|
|
2021 (June) | Ongoing |
| 1 | VISID - Vaccine naive Control - Visit 1 |
|
|
2021 (July) | Ongoing |
| 2 | VISID - Vaccine naive Control - Visit 2 |
|
|
2021 (August) | Ongoing |
| 3 | VISID - Vaccine naive Control - Follow-up 1 |
|
|
2021 (September) | Ongoing |
| 4 | VISID - Vaccine naive Control - Follow-up 2 |
|
|
2022 (January) | Ongoing |
VISID - Vaccine experienced subgroup A
The population is composed of patients who are 12 years old and older, vaccine experienced and have a predominant B cell defect.
These patiens have a primary antibody deficiency including but not limited to common variable immunodeficiency and x-linked agammaglobulinemia who are being treated or recently treated ( less than 6 months) with B-cell depleting therapy (e.g. rituximab, ocrelizumab) or with B-cell activating factor inhibitor (e.g. belimumab), including patients with immune-mediated diseases such as multiple sclerosis, rheumatoid arthritis, and granulomatous polyangiitis as well as patients with hematological malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine experienced subgroup A - Baseline |
|
2021 (February) | Ongoing | |
| 1 | VISID - Vaccine experienced subgroup A - Visit 1 |
|
|
2021 (August) | Ongoing |
| 2 | VISID - Vaccine experienced subgroup A - Visit 2 |
|
|
2021 (September) | Ongoing |
| 3 | VISID - Vaccine experienced subgroup A - Visit 3 |
|
|
2022 (February) | Ongoing |
VISID - Vaccine experienced subgroup B
The population is composed of patients who are 12 years old and older, vaccine experienced and with a combined B- and T-cell defect (Combined B-cell and T-cell immunodeficiency diagnosis).
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine experienced subgroup B - Baseline |
|
2021 (February) | Ongoing | |
| 1 | VISID - Vaccine experienced subgroup B - Visit 1 |
|
|
2021 (August) | Ongoing |
| 2 | VISID - Vaccine experienced subgroup B - Visit 2 |
|
|
2021 (September) | Ongoing |
| 3 | VISID - Vaccine experienced subgroup B - Visit 3 |
|
|
2022 (February) | Ongoing |
VISID - Vaccine experienced subgroup C
The population is composed of patients who are 12 years old and older, are vaccine experienced and have another inborn error of immunity including but not limited to non-transplanted chronic granulomatous disease, complement deficiency, and presence of autoantibodies to cytokines.
Selection Criteria
- Minimum age
-
12
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Other Criteria
-
Inclusion: Able to provide informed consent, able to speak either English or French, available for ongoing follow-up as required.
Exclusion: Subclass deficiency or isolated IgA deficiency without confirmatory testing for poor polysaccharide vaccine response, recent (<6 months) or concomitant use of other immunosuppressive agents (only for subgroup AII), evidence of HIV infection, contraindicated from receiving COVID-19 vaccines.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Potential participants were recruited from many sources, including specialty clinics for Immunology, Malignant Hematology, Neurology and Rheumatology as well as Medical Day Units and Public Health Immunization Clinics across Canada.
Sample Size
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | VISID - Vaccine experienced subgroup C - Baseline |
|
2021 (February) | Ongoing | |
| 1 | VISID - Vaccine experienced subgroup C - Visit 1 |
|
|
2021 (August) | Ongoing |
| 2 | VISID - Vaccine experienced subgroup C - Visit 2 |
|
|
2021 (September) | Ongoing |
| 3 | VISID - Vaccine experienced subgroup C - Visit 3 |
|
|
2022 (February) | Ongoing |
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
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-02-27T15:39:47.286