SafeTy and Efficacy of Preventative CoVID Vaccines

NCT ID: NCT05208983

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2024-04-30

Brief Summary

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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

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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)

Conditions

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COVID-19 Virus Infection Vaccine Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

mRNA Vaccines or Viral vector-based vaccines for COVID

Intervention Type BIOLOGICAL

Participants receiving an approved COVID 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

mRNA Vaccines or Viral vector-based vaccines for COVID

Intervention Type BIOLOGICAL

Participants receiving an approved COVID vaccine

Interventions

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mRNA Vaccines or Viral vector-based vaccines for COVID

Participants receiving an approved COVID vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Moderna Spikevax COVID-19 vaccine Pfizer-BioNTech Comirnaty COVID-19 vaccine AstraZeneca Vaxzevria COVID-19 vaccine Janssen (Johnson & Johnson) COVID-19 vaccine

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Walmsley, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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21-5090

Identifier Type: -

Identifier Source: org_study_id

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