SafeTy and Efficacy of Preventative CoVID Vaccines

Active, not recruiting

• Conditions: Vaccine Response; COVID-19 Virus Infection
• Interventions: Biological: mRNA Vaccines or Viral vector-based vaccines for COVID

• Registration Number: NCT05208983
• Lead Sponsor: University Health Network, Toronto

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)

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-01-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1286

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
70 years and Older	mRNA Vaccines or Viral vector-based vaccines for COVID	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	mRNA Vaccines or Viral vector-based vaccines for COVID	Persons aged 30 - 50 years receiving a first or second dose of an approved COVID-19 vaccine and a resident of Ontario

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada