SafeTy and Efficacy of Preventative CoVID Vaccines (STOPCoV)

University Health Network, Toronto

Status

Active, not recruiting

Conditions

Vaccine Response

COVID-19 Virus Infection

Treatments

Biological: mRNA Vaccines or Viral vector-based vaccines for COVID

Study type

Observational

Funder types

Other

Identifiers

NCT05208983

21-5090

Details and patient eligibility

About

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).

Full 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)

Enrollment

1,286 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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.