SafeTy and Efficacy of Preventative CoVID Vaccines

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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SafeTy and Efficacy of Preventative CoVID Vaccines

Conditions
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COVID-19 Virus Infection, Vaccine Response

Intervention / Treatment
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* Biological: mRNA Vaccines or Viral vector-based vaccines for COVID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be a resident of Ontario Arm A: Individuals aged 70 and over Speak, read and understand English (or have a trusted individual to help with study procedures) Will receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center. Individuals reaching the minimum age requirement by end of the recruitment calendar year are allowed to participate. Arm B: Individuals between age 30-50 years Speak, read and understand English (or have a trusted individual to help with study procedures) Receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center. Exclusion Criteria: Not a resident of Ontario Individuals who are < 30 years or those 51-69 years. Those who are unable to complete the study protocols in English either alone or with the assistance of a trusted individual with an electronic device. Participants who do not receive any dose of the vaccine Participants who have already received both doses of the vaccine prior to enrolment.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 70 years and Older<br>Persons aged 70 years and over receiving a first or second dose of an approved COVID-19 vaccine and is a resident of Ontario | Biological: mRNA Vaccines or Viral vector-based vaccines for COVID<br>* Participants receiving an approved COVID vaccine<br>* Other names: Janssen (Johnson & Johnson) COVID-19 vaccine;|
| 30 - 50 years of age<br>Persons aged 30 - 50 years receiving a first or second dose of an approved COVID-19 vaccine and a resident of Ontario | Biological: mRNA Vaccines or Viral vector-based vaccines for COVID<br>* Participants receiving an approved COVID vaccine<br>* Other names: Janssen (Johnson & Johnson) COVID-19 vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | determine the proportion, types and severity of adverse events after the booster dose | 48 weeks |