STOPCoV: SafeTy and Efficacy of Preventative CoVID Vaccines

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05208983
• Collaborator: COVID-19 Immunology Task Force (CITF) (Other), Canadian Institutes of Health Research (CIHR) (Other), Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)
• Enrollment: 1,286
• Location: 1
• Anticipated Duration (Months): 34.9
• Patients Per Site Per Month: 36.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Virus Infection; Vaccine Response	Biological: mRNA Vaccines or Viral vector-based vaccines for COVID

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 Design

• Study Type: Observational
• Actual Enrollment: 1286 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SafeTy and Efficacy of Preventative CoVID Vaccines
• Actual Study Start Date: May 6, 2021
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Safety of COVID-19 Vaccines [48 weeks]

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

Other Outcome Measures

1. Breakthrough COVID Infection [48 Weeks after the final vaccine dose]

   number of persons who develop COVID post vaccination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• University Health Network, Toronto
• COVID-19 Immunology Task Force (CITF)
• Canadian Institutes of Health Research (CIHR)
• Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

• Principal Investigator: Sharon Walmsley, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study Website

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT05208983
• Other Study ID Numbers: 21-5090
• First Posted: Jan 26, 2022
• Last Update Posted: May 26, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Vaccines

Study Results

No Results Posted as of May 26, 2022