NCT05208983

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

January 24, 2022

Last Update Submit

January 3, 2023

Conditions

COVID-19 Virus InfectionVaccine Response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Antibody Levels at different timepoints

    48 Weeks

  • Safety of COVID-19 Vaccines

    48 weeks

Other Outcomes (1)

  • Breakthrough COVID Infection

    48 Weeks after the final vaccine dose

Study Arms (2)

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

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

Interventions

mRNA Vaccines or Viral vector-based vaccines for COVIDBIOLOGICAL

Participants receiving an approved COVID vaccine

Also known as: 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 age70 years and Older

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Dry Blood Spot specimen samples will be analyzed for vaccine induced antibodies. Remaining samples will be retained for up to 5 years

MeSH Terms

Conditions

COVID-19

Interventions

mRNA Vaccines2019-nCoV Vaccine mRNA-1273COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based VaccinesVaccines, SyntheticRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsVaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex MixturesAntigensBiological FactorsViral Vaccines

Study Officials

  • Sharon Walmsley, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

January 26, 2022

Study Start

May 6, 2021

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Data Sharing will be aggregate and de-identified

Locations

CA(1)