Clinical trial NCT05208983: SafeTy and Efficacy of Preventative CoVID Vaccines
Official title: SafeTy and Efficacy of Preventative CoVID Vaccines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Virus Infection
Vaccine Response
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
name: Public Health Agency of Canada (PHAC)
First posted: 2022-01-26
Enrollment: 1286
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 911 individuals ages 70 and over enrolled and 375 ages 30 - 50 enrolled

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)

Eligibility criteria: 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.

Primary outcomes:
measure: COviD-19 vaccine specific antibody levels
timeFrame: 24 weeks after the final vaccination.
Secondary outcomes:
measure: Antibody Levels at different timepoints
timeFrame: 48 Weeks
measure: Safety of COVID-19 Vaccines
timeFrame: 48 weeks
Other outcomes:
measure: Breakthrough COVID Infection
timeFrame: 48 Weeks after the final vaccine dose
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Sharon Walmsley, MD
role: PRINCIPAL_INVESTIGATOR
References: