Prospective Cohort Study to Examine Immunogenicity of SARS-CoV-2 Vaccination in Cancer Patients with Solid Malignancies
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.
Overview
- Acronym
- ICoVVaC
- Investigators
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- Contacts
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General Design
- Study design
- Cohort
- Start - End Year
- 2021 -
- General Information on Follow Up (profile, frequency)
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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).
- Recruitment Target
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- Individuals
- Number of Participants
- 216
- Number of Participants with Biological Samples
- 216
- Supplementary information about number of participants
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Cohort A: 72 participants
Cohort B: 82 participants
Cohort C: 62 participants - Supplementary Information
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Participants are joining the study at different timepoints in their vaccination journey and not all visits apply to all participants.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
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Timeline
Populations
ICoVVaC - Cohort A
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
- Countries
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- Canada
- Canadian Provinces
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- Ontario
- Territory
- Ottawa
- 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
Sources of Recruitment
- 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).
Sample Size
- Number of Participants
- 72
- Number of Participants with Biological Samples
- 72
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ICoVVaC - Cohort A - Baseline |
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2021 (July) | 2022 (October) |
| 1 | ICoVVaC - Cohort A - Pre-dose 2 |
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2021 (July) | 2023 (January) |
| 2 | ICoVVaC - Cohort A - 4 weeks post-dose 2 |
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2021 (August) | 2023 (January) |
| 3 | ICoVVaC - Cohort A - 3 months post-dose 2 |
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2021 (October) | 2023 (January) |
| 4 | ICoVVaC - Cohort A - 6 months post-dose 2 |
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2022 (January) | 2023 (January) |
| 5 | ICoVVaC - Cohort A - 12 months post-dose 2 |
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2022 (July) | 2023 (January) |
| 6 | ICoVVaC - Cohort A - Pre-dose 3 |
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2021 (July) | 2023 (January) |
| 7 | ICoVVaC - Cohort A - 4 weeks post-dose 3 |
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2021 (August) | 2023 (January) |
| 8 | ICoVVaC - Cohort A - 3 months post-dose 3 |
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2021 (October) | 2023 (January) |
| 9 | ICoVVaC - Cohort A - 6 months post-dose 3 |
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2022 (January) | 2023 (January) |
| 10 | ICoVVaC - Cohort A - 12 months post-dose 3 |
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2022 (July) | 2023 (January) |
| 11 | ICoVVaC - Cohort A - Pre-dose 4 |
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2021 (July) | 2023 (January) |
| 12 | ICoVVaC - Cohort A - 4 weeks post-dose 4 |
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2021 (August) | 2023 (January) |
| 13 | ICoVVaC - Cohort A - 3 months post-dose 4 |
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2021 (October) | 2023 (January) |
| 14 | ICoVVaC - Cohort A - 6 months post-dose 4 |
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2022 (January) | 2023 (January) |
ICoVVaC - Cohort B
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
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18
- Countries
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- Canada
- Canadian Provinces
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- British Columbia
- Ontario
- Territory
- Ottawa and Vancouver
- Health Status
-
- 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
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
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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.
Sample Size
- Number of Participants
- 82
- Number of Participants with Biological Samples
- 82
- Supplementary information about number of participants
-
Ottawa Hospital: 75 participants
Vancouver BC Cancer: 75 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ICoVVaC - Cohort B - Baseline |
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|
2021 (July) | 2022 (October) |
| 1 | ICoVVaC - Cohort B - Pre-dose 2 |
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|
2021 (July) | 2023 (January) |
| 2 | ICoVVaC - Cohort B - 4 weeks post-dose 2 |
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2021 (August) | 2023 (January) |
| 3 | ICoVVaC - Cohort B - 3 months post-dose 2 |
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2021 (October) | 2023 (January) |
| 4 | ICoVVaC - Cohort B - 6 months post-dose 2 |
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2022 (January) | 2023 (January) |
| 5 | ICoVVaC - Cohort B - 12 months post-dose 2 |
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2022 (July) | 2023 (January) |
| 6 | ICoVVaC - Cohort B - Pre-dose 3 |
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2021 (July) | 2023 (January) |
| 7 | ICoVVaC - Cohort B - 4 weeks post-dose 3 |
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2021 (August) | 2023 (January) |
| 8 | ICoVVaC - Cohort B - 3 months post-dose 3 |
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2021 (October) | 2023 (January) |
| 9 | ICoVVaC - Cohort B - 6 months post-dose 3 |
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2022 (January) | 2023 (January) |
| 10 | ICoVVaC - Cohort B - 12 months post-dose 3 |
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2022 (July) | 2023 (January) |
| 11 | ICoVVaC - Cohort B - Pre-dose 4 |
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2021 (July) | 2023 (January) |
| 12 | ICoVVaC - Cohort B - 4 weeks post-dose 4 |
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2021 (August) | 2023 (January) |
| 13 | ICoVVaC - Cohort B - 3 months post-dose 4 |
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2021 (October) | 2023 (January) |
| 14 | ICoVVaC - Cohort B - 6 months post-dose 4 |
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2022 (January) | 2023 (January) |
ICoVVaC - Cohort C
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
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Ontario
- Territory
- Ottawa and Vancouver
- 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
Sources of Recruitment
- 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.
Sample Size
- Number of Participants
- 150
- Number of Participants with Biological Samples
- 150
- Supplementary information about number of participants
-
Ottawa Hospital: 75 participants
Vancouver BC Cancer: 75 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ICoVVaC - Cohort C - Baseline |
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|
2021 (July) | 2022 (October) |
| 1 | ICoVVaC - Cohort C - Pre-dose 2 |
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2021 (July) | 2023 (January) |
| 2 | ICoVVaC - Cohort C - 4 weeks post-dose 2 |
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2021 (August) | 2023 (January) |
| 3 | ICoVVaC - Cohort C - 3 months post-dose 2 |
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2021 (October) | 2023 (January) |
| 4 | ICoVVaC - Cohort C - 6 months post-dose 2 |
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2022 (January) | 2023 (January) |
| 5 | ICoVVaC - Cohort C - 12 months post-dose 2 |
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2022 (July) | 2023 (January) |
| 6 | ICoVVaC - Cohort C - Pre-dose 3 |
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2021 (July) | 2023 (January) |
| 7 | ICoVVaC - Cohort C - 4 weeks post-dose 3 |
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2021 (August) | 2023 (January) |
| 8 | ICoVVaC - Cohort C - 3 months post-dose 3 |
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2021 (October) | 2023 (January) |
| 9 | ICoVVaC - Cohort C - 6 months post-dose 3 |
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2022 (January) | 2023 (January) |
| 10 | ICoVVaC - Cohort C - 12 months post-dose 3 |
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2022 (July) | 2023 (January) |
| 11 | ICoVVaC - Cohort C - Pre-dose 4 |
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2021 (July) | 2023 (January) |
| 12 | ICoVVaC - Cohort C - 4 weeks post-dose 4 |
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2021 (August) | 2023 (January) |
| 13 | ICoVVaC - Cohort C - 3 months post-dose 4 |
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2021 (October) | 2023 (January) |
| 14 | ICoVVaC - Cohort C - 6 months post-dose 4 |
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2022 (January) | 2023 (January) |
Participating Studies
| Acronym | Name | Study design | Countries |
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Harmonization Initiatives Included
| Acronym | Name |
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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: 2023-05-15T15:09:23.373