SafeTy and Efficacy of Preventative CoVID Vaccines (STOPCoV)

January 3, 2023 updated by: University Health Network, Toronto
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

1286

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

911 individuals ages 70 and over enrolled and 375 ages 30 - 50 enrolled

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Biological: mRNA Vaccines or Viral vector-based vaccines for COVID
Participants receiving an approved COVID vaccine
Other Names:
  • Moderna Spikevax COVID-19 vaccine
  • Pfizer-BioNTech Comirnaty COVID-19 vaccine
  • AstraZeneca Vaxzevria COVID-19 vaccine
  • Janssen (Johnson & Johnson) COVID-19 vaccine
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
Biological: mRNA Vaccines or Viral vector-based vaccines for COVID
Participants receiving an approved COVID vaccine
Other Names:
  • Moderna Spikevax COVID-19 vaccine
  • Pfizer-BioNTech Comirnaty COVID-19 vaccine
  • AstraZeneca Vaxzevria COVID-19 vaccine
  • Janssen (Johnson & Johnson) COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks after the final vaccination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 Weeks
Safety of COVID-19 Vaccines
Time Frame: 48 weeks
determine the proportion, types and severity of adverse events after the booster dose
48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breakthrough COVID Infection
Time Frame: 48 Weeks after the final vaccine dose
number of persons who develop COVID post vaccination
48 Weeks after the final vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Public Health Agency of Canada (PHAC)

Investigators

  • Principal Investigator: sharon walmsley, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-5090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data Sharing will be aggregate and de-identified

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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