SafeTy and Efficacy of Preventative CoVID Vaccines

COVID-19 Virus Infection Clinical Trial

— STOPCoV  

Official title:

SafeTy and Efficacy of Preventative CoVID Vaccines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05208983
• Other study ID #: 21-5090
• Status: Active, not recruiting
• Start date: May 6, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1286
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Virus Infection
• Vaccine Response

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC), Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breakthrough COVID Infection	number of persons who develop COVID post vaccination	48 Weeks after the final vaccine dose
Primary	COviD-19 vaccine specific antibody levels	The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies	24 weeks after the final vaccination.
Secondary	Antibody Levels at different timepoints	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
Secondary	Safety of COVID-19 Vaccines	determine the proportion, types and severity of adverse events after the booster dose	48 weeks

External Links

•   Study Website