COVID-19 Virus Infection, Vaccine Response
Conditions
Brief summary
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
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)
Interventions
BIOLOGICALmRNA Vaccines or Viral vector-based vaccines for COVID
Participants receiving an approved COVID vaccine
Sponsors
Canadian Institutes of Health Research (CIHR)
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Public Health Agency of Canada (PHAC)
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COviD-19 vaccine specific antibody levels | 24 weeks after the final vaccination. | The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Levels at different timepoints | 48 Weeks | 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 |
| Safety of COVID-19 Vaccines | 48 weeks | determine the proportion, types and severity of adverse events after the booster dose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Breakthrough COVID Infection | 48 Weeks after the final vaccine dose | number of persons who develop COVID post vaccination |
Countries
Canada
Outcome results
None listed