COVID-19 Virus InfectionSTOPCoVNCT05208983
SafeTy and Efficacy of Preventative CoVID Vaccines
An observational study of COVID-19 Virus Infection and Vaccine Response, run by University Health Network, Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Virus Infection, Vaccine Response
- What is being tested?
- mRNA Vaccines or Viral vector-based vaccines for COVID
- Type of treatment
- Vaccines
- How many people
- 1,286 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2021to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 911 individuals ages 70 and over enrolled and 375 ages 30 - 50 enrolled
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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)
- Conditions
- COVID-19 Virus Infection, Vaccine Response
- Being tested
- mRNA Vaccines or Viral vector-based vaccines for COVID
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA Vaccines or Viral vector-based vaccines for COVIDBiological
Also called Moderna Spikevax COVID-19 vaccine, Pfizer-BioNTech Comirnaty COVID-19 vaccine, AstraZeneca Vaxzevria COVID-19 vaccine, Janssen (Johnson & Johnson) COVID-19 vaccine
Participants receiving an approved COVID vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: mRNA Vaccines or Viral vector-based vaccines for COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
COviD-19 vaccine specific antibody levels
The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies
Measured: 24 weeks after the final vaccination.
Secondary outcomes (2)
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
Measured: 48 Weeks
Safety of COVID-19 Vaccines
determine the proportion, types and severity of adverse events after the booster dose
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start6 May 2021
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Virus InfectionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
- Investigators
- Sharon Walmsley, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208983
- Sponsor's protocol ID
- 21-5090
- Acronym
- STOPCoV
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Sharing will be aggregate and de-identified
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeTy and Efficacy of Preventative CoVID Vaccines
- ClinicalTrials.gov ID
- NCT05208983
- Acronym / sponsor ID
- STOPCoV / 21-5090
- Conditions
- COVID-19 Virus Infection, Vaccine Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,286 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Public Health Agency of Canada (PHAC)
- Study start
- 6 May 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 70 years and Older | – | Biological: mRNA Vaccines or Viral vector-based vaccines for COVIDPersons 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 | – | Biological: mRNA Vaccines or Viral vector-based vaccines for COVIDPersons aged 30 - 50 years receiving a first or second dose of an approved COVID-19 vaccine and a resident of Ontario |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 911 individuals ages 70 and over enrolled and 375 ages 30 - 50 enrolled
Key inclusion criteria (9 listed)
- Must be a resident of Ontario
- 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.
- Individuals between age 30-50 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA Vaccines or Viral vector-based vaccines for COVIDAlso: Moderna Spikevax COVID-19 vaccine, Pfizer-BioNTech Comirnaty COVID-19 vaccine, AstraZeneca Vaxzevria COVID-19 vaccine, Janssen (Johnson & Johnson) COVID-19 vaccineParticipants receiving an approved COVID vaccine | Biological | 30 - 50 years of age, 70 years and Older |
Primary outcome
COviD-19 vaccine specific antibody levels
Time frame: 24 weeks after the final vaccination.
The ratio-normalized levels of anti-spike and anti-RBD IgG antibodies
2 secondary outcomes
Antibody Levels at different timepoints
Time frame: 48 Weeks
Safety of COVID-19 Vaccines
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data Sharing will be aggregate and de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Walmsley, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Virus Infection and Vaccine Response, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COviD-19 vaccine specific antibody levels (time frame: 24 weeks after the final vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.