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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Samuel Lunenfeld Research Institute, Mount Sinai Hospital | OTHER |
| Public Health Agency of Canada (PHAC) | OTHER_GOV |
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The STOPCoV study is a decentralized study comparing COVID-19 vaccine specific antibody levels at 24 weeks after final vaccine dose. We plan to study the safety and immunogenicity of COVID-19 vaccine(s) in community dwelling persons 70 years and over relative to a younger group (aged 30 - 50 years).
This is a prospective observational study of a cohort of individuals aged 30-50 years and a cohort of individuals aged 70 years and over receiving the COVID-19 vaccine.
Participants will complete a questionnaire to determine eligibility. Eligible participants will complete and sign an e-consent and then be provided with a participant ID, log in information and password to the database portal, and then be enrolled into the study.
Participants will complete the study assessments (baseline questionnaire, post vaccine symptom e-diary monthly, check-in questionnaire and dried blood spot specimens)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 70 years and Older | Persons aged 70 years and over receiving a first or second dose of an approved COVID-19 vaccine and is a resident of Ontario |
| |
| 30 - 50 years of age | Persons aged 30 - 50 years receiving a first or second dose of an approved COVID-19 vaccine and a resident of Ontario |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA Vaccines or Viral vector-based vaccines for COVID | Biological | Participants receiving an approved COVID vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| COviD-19 vaccine specific antibody levels | The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies | 24 weeks after the final vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Levels at different timepoints | baseline, 3 weeks after first vaccine dose, prior to second dose and then at 2, 12, 36 and 48 weeks after the final vaccine dose | 48 Weeks |
| Safety of COVID-19 Vaccines |
| Measure | Description | Time Frame |
|---|---|---|
| Breakthrough COVID Infection | number of persons who develop COVID post vaccination | 48 Weeks after the final vaccine dose |
Inclusion Criteria:
Arm A:
Arm B:
Exclusion Criteria:
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911 individuals ages 70 and over enrolled and 375 ages 30 - 50 enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Walmsley, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
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| Label | URL |
|---|---|
| Study Website | View source |
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Data Sharing will be aggregate and de-identified
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
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Dry Blood Spot specimen samples will be analyzed for vaccine induced antibodies. Remaining samples will be retained for up to 5 years
|
determine the proportion, types and severity of adverse events after the booster dose
| 48 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D014765 | Viral Vaccines |