SafeTy and Efficacy of Preventative CoVID Vaccines

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).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2024

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

  • Biological: mRNA Vaccines or Viral vector-based vaccines for COVID
    • Participants receiving an approved COVID vaccine

Arms, Groups and Cohorts

  • 70 years and Older
    • Persons aged 70 years and over receiving a first or second dose of an approved COVID-19 vaccine and is a resident of Ontario
  • 30 – 50 years of age
    • Persons aged 30 – 50 years receiving a first or second dose of an approved COVID-19 vaccine and a resident of Ontario

Clinical Trial Outcome Measures

Primary Measures

  • COviD-19 vaccine specific antibody levels
    • Time Frame: 24 weeks after the final vaccination.
    • The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies

Secondary Measures

  • Antibody Levels at different timepoints
    • Time Frame: 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
    • Time Frame: 48 weeks
    • determine the proportion, types and severity of adverse events after the booster dose

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sharon Walmsley, MD, Principal Investigator, University Health Network, Toronto

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