Prospective Cohort Study to Examine Immunogenicity of SARS-CoV-2 Vaccination in Cancer Patients with Solid Malignancies
Networks
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Datasets
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Variables
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The primary objective of this study is tointerrogate the immunogenicity of authorized SARS-CoV-2 vaccinesin multiple cohorts of cancer patients (on and off treatment) compared to healthy controls. The primary analyses will be the comparison of humoral immune responses, defined as IgG against the SARS-CoV-2 spike protein, between healthy controls and cancer cohorts at 4 weeks post any vaccinedose.
The secondary objectives are to compare cancer patients with solid tumours, not on cytotoxic therapy (Cohort B) and cancer patients with solid tumours, on cytotoxic
chemotherapy (Cohort C) to healthy subjects (Cohort A) with regards to the following:
* IgG against the SARS-CoV-2 full spike protein, receptor binding domain (RBD), nucleocapsid protein (NP) and N-terminal domain (NTD) of SARS-CoV-2 and spike proteins of 4 seasonal coronaviruses (OC43, HKU1, NL63, and 229E) at all study time points that can be collected, up to 7 total.
* Cell-mediated immunity in a sub-set of participants at 3-7selected timepoints.
* Neutralizing antibody assay against the SARS-CoV-2 spike protein at 3-7 timepoints.
* Evaluation of IgM and IgA against the SARS-CoV-2 full spike, RBD, NP andNTD of SARS-CoV-2 and spike of 4 seasonal coronavirus (OC43, HKU1, NL63, and 229E) at 3-7 timepoints.
The exploratory objectives are :
* To explore the immunogenicity as outlined above in embeded subgroups, such as solid tumours on immune check point inhibitor therapy (likely subset of cohort B).
* To explore the occurrence of symptomatic or asymptomatic COVID-19 infection as determined by participant self-reporting or the emergence of nucleocapsid antibodies during the study.
* To explore the correlation of IgG responses with IgA, IgM and neutralization responses and cell mediated immune responses.
* To identify baseline biomarkers which predict antibody and/or T cell responses and adverse events following immunization (a subgroup of 100 individuals from cohorts B & C).
* To explore safety and effectiveness of vaccines by collaborating with British Columbia Centre for Disease Control (BCCDC) and Public Health Ontario (PHO), and with the Canadian National Vaccine Safety (CANVAS) Network for vaccine safety surveillance.
- Start Year
- 2021
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Follow Up
- When possible, participants are followed from pre-vaccine through 12 months following their second or third dose of vaccine, or up to 6 months post dose 4 (if applicable).
- Supplementary Information
- Participants are joining the study at different timepoints in their vaccination journey and not all visits apply to all participants.
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
- Supplementary Information
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Cohort A: 72 participants
Cohort B: 82 participants
Cohort C: 62 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
The population is composed of healthy subjects who at first were not vaccinated but are receiving COVID-19 vaccination as part of the national vaccine roll-out (standard of care) and included in the study within 4 weeks of the second dose of vaccine.
Selection Criteria
- Minimum age
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18
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ottawa
- Ethnic Origin
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- Health Status
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- Healthy
- Other Criteria
- Inclusion: Patients who will be receiving COVID-19 vaccination and are within 4 weeks of the second dose of vaccine
Recruitment
- Sources of recruitment
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- General population
- General Population
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- Volunteer enrolment
- Supplementary Information
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Participants were recruited by self-referral, or after receiving promotion of study through social media (Twitter, Facebook), or visiting the cancer centre and hospital (where posters about the study are displayed).
Number of Participants
- Number of Participants
- 72
- Number of Participants with Biological Samples
- 72
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ICoVVaC - Cohort A - Baseline
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-07 | 2022-10 |
| 1 |
ICoVVaC - Cohort A - Pre-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 2 |
ICoVVaC - Cohort A - 4 weeks post-dose 2
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 3 |
ICoVVaC - Cohort A - 3 months post-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-10 | 2023-01 |
| 4 |
ICoVVaC - Cohort A - 6 months post-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2022-01 | 2023-01 |
| 5 |
ICoVVaC - Cohort A - 12 months post-dose 2
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected.Information on assessment of clinical outcomes (incidence of COVID-19) and patient ... | 2022-07 | 2023-01 |
| 6 |
ICoVVaC - Cohort A - Pre-dose 3
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 7 |
ICoVVaC - Cohort A - 4 weeks post-dose 3
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 8 |
ICoVVaC - Cohort A - 3 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 9 |
ICoVVaC - Cohort A - 6 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
| 10 |
ICoVVaC - Cohort A - 12 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-07 | 2023-01 |
| 11 |
ICoVVaC - Cohort A - Pre-dose 4
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 12 |
ICoVVaC - Cohort A - 4 weeks post-dose 4
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 13 |
ICoVVaC - Cohort A - 3 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 14 |
ICoVVaC - Cohort A - 6 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
The population is composed of cancer patients with solid tumours from cancer clinics at the Ottawa Hospital and at Vancouver BC Cancer, who were not on chemotherapy and who are going to receive COVID-19 vaccination as part of the national vaccine roll-out (standard of care) and included in the study within 4 weeks of the second dose of vaccine.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ottawa and Vancouver
- Ethnic Origin
-
- Health Status
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- Patients who have solid tumours
- Other Criteria
- Inclusion: Patients who are not on chemotherapy and receiving COVID-19 vaccination or are within 4 weeks of the second dose of vaccine
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants were recruited from cancer clinics at the Ottawa Hospital and at Vancouver BC Cancer. Some participants were self-referred after reading study-related press releases on social media.
Number of Participants
- Number of Participants
- 82
- Number of Participants with Biological Samples
- 82
- Supplementary Information about selection criteria
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Ottawa Hospital: 75 participants
Vancouver BC Cancer: 75 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ICoVVaC - Cohort B - Baseline
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-07 | 2022-10 |
| 1 |
ICoVVaC - Cohort B - Pre-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 2 |
ICoVVaC - Cohort B - 4 weeks post-dose 2
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 3 |
ICoVVaC - Cohort B - 3 months post-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-10 | 2023-01 |
| 4 |
ICoVVaC - Cohort B - 6 months post-dose 2
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Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2022-01 | 2023-01 |
| 5 |
ICoVVaC - Cohort B - 12 months post-dose 2
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected.Information on assessment of clinical outcomes (incidence of COVID-19) and patient ... | 2022-07 | 2023-01 |
| 6 |
ICoVVaC - Cohort B - Pre-dose 3
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 7 |
ICoVVaC - Cohort B - 4 weeks post-dose 3
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 8 |
ICoVVaC - Cohort B - 3 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 9 |
ICoVVaC - Cohort B - 6 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
| 10 |
ICoVVaC - Cohort B - 12 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-07 | 2023-01 |
| 11 |
ICoVVaC - Cohort B - Pre-dose 4
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 12 |
ICoVVaC - Cohort B - 4 weeks post-dose 4
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 13 |
ICoVVaC - Cohort B - 3 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 14 |
ICoVVaC - Cohort B - 6 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
The population is composed of cancer patients with solid tumours from cancer clinics at the Ottawa Hospital and at Vancouver BC Cancer, who were on chemotherapy and who are going to receive COVID-19 vaccination as part of the national vaccine roll-out (standard of care) and included in the study within 4 weeks of the second dose of vaccine.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ottawa and Vancouver
- Ethnic Origin
-
- Health Status
-
- Patients who have solid tumours
- Other Criteria
- Inclusion: Patients who are on chemotherapy and will be receiving COVID-19 vaccination or are within 4 weeks of the second dose of vaccine
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants were recruited from cancer clinics at the Ottawa Hospital and at Vancouver BC Cancer. Some participants were self-referred after reading study-related press releases on social media.
Number of Participants
- Number of Participants
- 150
- Number of Participants with Biological Samples
- 150
- Supplementary Information about selection criteria
-
Ottawa Hospital: 75 participants
Vancouver BC Cancer: 75 participants
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ICoVVaC - Cohort C - Baseline
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-07 | 2022-10 |
| 1 |
ICoVVaC - Cohort C - Pre-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 2 |
ICoVVaC - Cohort C - 4 weeks post-dose 2
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 3 |
ICoVVaC - Cohort C - 3 months post-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-10 | 2023-01 |
| 4 |
ICoVVaC - Cohort C - 6 months post-dose 2
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2022-01 | 2023-01 |
| 5 |
ICoVVaC - Cohort C - 12 months post-dose 2
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected.Information on assessment of clinical outcomes (incidence of COVID-19) and patient ... | 2022-07 | 2023-01 |
| 6 |
ICoVVaC - Cohort C - Pre-dose 3
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 7 |
ICoVVaC - Cohort C - 4 weeks post-dose 3
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 8 |
ICoVVaC - Cohort C - 3 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 9 |
ICoVVaC - Cohort C - 6 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
| 10 |
ICoVVaC - Cohort C - 12 months post-dose 3
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-07 | 2023-01 |
| 11 |
ICoVVaC - Cohort C - Pre-dose 4
|
Information on assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood (serum and peripheral blood mononuclear cells ... | 2021-07 | 2023-01 |
| 12 |
ICoVVaC - Cohort C - 4 weeks post-dose 4
|
Information on demographics, vaccine details, assessment of clinical outcomes (incidence of COVID-19) and patient self-reported COVID-19 testing results was collected. Blood samples (serum and ... | 2021-08 | 2023-01 |
| 13 |
ICoVVaC - Cohort C - 3 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2021-10 | 2023-01 |
| 14 |
ICoVVaC - Cohort C - 6 months post-dose 4
|
Information on vaccine information and assessment of clinical outcomes (incidence of COVID-19) was collected. Blood (serum and peripheral blood mononuclear cells (PBMCs) samples were collected. | 2022-01 | 2023-01 |
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
Education
Residence
Ethnicity, race and religion
Lifestyle and behaviours
Tobacco
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)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the genitourinary system (N00-N99)
Symptoms and signs
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Non-pharmacological interventions
Laboratory diagnosis interventions
Health and community care services utilization
Hospitalizations
Death
Vital status
Physical measures and assessments
Anthropometry
Laboratory measures
Immunology
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