Vaccine Immunogenicity and Safety in ImmunoDeficient Patients
Networks
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Datasets
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Variables
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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.
- Start Year
- 2021
- End Year
- 2022
Visit VISID
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Follow Up
- 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
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 4,000
- Number of Participants with Biological Samples
- Supplementary Information
- he Vaccine Immunogenicity and Safety in ImmunoDeficient Patients study is a national prospective cohort aiming to enroll approximately 3,000–4,000 immunocompromised individuals.”
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
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
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12
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ethnic Origin
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- Health Status
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- Other Criteria
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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.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine naive subgroup A - Baseline
|
Information was collected about medical history, and concomitant medications. A blood sample was collected. | 2021-06 | |
| 1 |
VISID - Vaccine naive subgroup A - Visit 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-07 | |
| 2 |
VISID - Vaccine naive subgroup A - Visit 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-08 | |
| 3 |
VISID - Vaccine naive subgroup A - Follow-up 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-09 | |
| 4 |
VISID - Vaccine naive subgroup A - Follow-up 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2022-01 |
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
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12
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine naive subgroup B - Baseline
|
Information was collected about medical history, and concomitant medications. A blood sample was collected. | 2021-06 | |
| 1 |
VISID - Vaccine naive subgroup B - Visit 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-07 | |
| 2 |
VISID - Vaccine naive subgroup B - Visit 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-08 | |
| 3 |
VISID - Vaccine naive subgroup B - Follow-up 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-09 | |
| 4 |
VISID - Vaccine naive subgroup B - Follow-up 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2022-01 |
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
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine naive subgroup C - Baseline
|
Information was collected about medical history, and concomitant medications. A blood sample was collected. | 2021-06 | |
| 1 |
VISID - Vaccine naive subgroup C - Visit 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-07 | |
| 2 |
VISID - Vaccine naive subgroup C - Visit 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-08 | |
| 3 |
VISID - Vaccine naive subgroup C - Follow-up 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-09 | |
| 4 |
VISID - Vaccine naive subgroup C - Follow-up 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2022-01 |
The population is composed of participants who are 12 years old and older, are vaccine naive and immunocompetent.
Selection Criteria
- Minimum age
-
12
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
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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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine naive Control - Baseline
|
Information was collected about medical history, and concomitant medications. A blood sample was collected. | 2021-06 | |
| 1 |
VISID - Vaccine naive Control - Visit 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-07 | |
| 2 |
VISID - Vaccine naive Control - Visit 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-08 | |
| 3 |
VISID - Vaccine naive Control - Follow-up 1
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2021-09 | |
| 4 |
VISID - Vaccine naive Control - Follow-up 2
|
Information was collected about medical history, concomitant medications, vaccine administration and adverse events. A blood sample was collected. | 2022-01 |
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
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine experienced subgroup A - Baseline
|
Information was collected about medical history and physical examination, concomitant medications. | 2021-02 | |
| 1 |
VISID - Vaccine experienced subgroup A - Visit 1
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-08 | |
| 2 |
VISID - Vaccine experienced subgroup A - Visit 2
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-09 | |
| 3 |
VISID - Vaccine experienced subgroup A - Visit 3
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2022-02 |
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
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine experienced subgroup B - Baseline
|
Information was collected about medical history and physical examination, concomitant medications. | 2021-02 | |
| 1 |
VISID - Vaccine experienced subgroup B - Visit 1
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-08 | |
| 2 |
VISID - Vaccine experienced subgroup B - Visit 2
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-09 | |
| 3 |
VISID - Vaccine experienced subgroup B - Visit 3
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2022-02 |
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
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- 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.
Recruitment
- Sources of recruitment
-
- Specific population
- 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.
Number of Participants
- Number of Participants
- 33
- Number of Participants with Biological Samples
- 33
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
VISID - Vaccine experienced subgroup C - Baseline
|
Information was collected about medical history and physical examination, concomitant medications. | 2021-02 | |
| 1 |
VISID - Vaccine experienced subgroup C - Visit 1
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-08 | |
| 2 |
VISID - Vaccine experienced subgroup C - Visit 2
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2021-09 | |
| 3 |
VISID - Vaccine experienced subgroup C - Visit 3
|
Information was collected about medical history, physical examination, concomitant medications and adverse events. A blood sample was collected. | 2022-02 |
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
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Family and household structure
Education
Residence
Ethnicity, race and religion
Language
Labour force and retirement
Lifestyle and behaviours
Tobacco
Alcohol
Drugs
Breastfeeding
Birth, pregnancy and reproductive health history
Pregnancy, delivery and birth
Perception of health, quality of life, development and functional limitations
Perception of health
Diseases
Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the eye and adnexa (H00-H59)
Diseases of the ear and mastoid process (H60-H95)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the skin and subcutaneous tissue (L00-L99)
Diseases of the musculoskeletal system and connective tissue (M00-M99)
Diseases of the genitourinary system (N00-N99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Symptoms and signs involving the circulatory and respiratory systems (R00-R09)
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving the skin and subcutaneous tissue (R20-R23)
Symptoms and signs involving nervous and musculoskeletal systems (R25-R29)
Symptoms and signs involving the urinary system (R30-R39)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Posology and protocol of administration
Non-pharmacological interventions
Surgical interventions
Radiological interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Community and social care
Other health and community care
Death
Vital status
Cause of death
Physical measures and assessments
Physical characteristics
Anthropometry
Circulation and respiration
Muscles, skeleton and mobility
Brain and nerves
Skin and subcutaneous tissue
Digestion
Reproduction
Other physical measures and assessments
Laboratory measures
Hematology
Biochemistry
Immunology
Preschool, school and work life
Work life
Physical environment
Housing characteristics
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Data and sample collection center-related information
Other administrative information