SafeTy and Efficacy of Preventative CoVID Vaccines

N/AUnknownNCT05208983

University Health Network, Toronto1,286 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

1,286

Conditions

COVID-19 Virus Infection Vaccine Response

Interventions

mRNA Vaccines or Viral vector-based vaccines for COVIDBIOLOGICAL

Participants receiving an approved COVID vaccine

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

COviD-19 vaccine specific antibody levels

The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies

Time frame: 24 weeks after the final vaccination.

Secondary Outcomes

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

Time frame: 48 Weeks

Safety of COVID-19 Vaccines

determine the proportion, types and severity of adverse events after the booster dose

Time frame: 48 weeks

Data from ClinicalTrials.gov

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