SafeTy and Efficacy of Protective COVID-19 Vaccines
The primary objective of this study is to compare COVID-19 vaccine specific antibody levels at 24 weeks after final vaccine dose in persons 70 years and over relative to younger cohort (aged 30 – 50 years).
The secondary objectives are:
1. To compare COVID-19 vaccine specific antibody levels at baseline, 3 weeks after first vaccine dose, prior to second dose (if second dose delayed more than 28 days) and then at 2, 12, 36 and 48 weeks after the final vaccine dose between those more than 70 years of age and those 30-50 years of age.
2. To compare the safety of COVID-19 vaccines between those 70 years and over to those between 30-50 years of age.
The exploratory objectives are:
1. To determine the relationship between the presence and severity of systemic and local vaccine reactions at 24 hours after each vaccine dose and the ratio-normalized levels of anti-spike and anti-RBD IgG antibodies after each vaccine dose.
2. To determine the number and types of adverse vaccine reactions that persist to 6 months past the second vaccine dose.
3. To determine the number of persons who develop a new COVID infection up to 48 weeks following final vaccine dose.
Overview
- Acronym
- StopCoV
- Website
- StopCoV
- Investigators
-
- Contacts
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General Design
- Study design
- Cohort
- Start - End Year
- 2020 -
- General Information on Follow Up (profile, frequency)
-
Participants are followed for 48 weeks after final vaccine dose for COVID-19 (at 7 days and 3 weeks post-1st vaccine dose, and 2 weeks, 12 weeks, 24 weeks post-2nd vaccine dose), then followed-up monthly. Participants also kept an eDiary for a 7-day period after each vaccine dose or booster throughout the study.
- Recruitment Target
-
- Individuals
- Number of Participants
- 1,300
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
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Timeline
Populations
StopCoV - 30-50 year olds
The population is composed of individuals between the ages of 30 and 50 years old that will receive or have received a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center.
Selection Criteria
- Minimum age
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30
- Maximum age
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50
- Countries
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- Canada
- Canadian Provinces
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- Ontario
- Other Criteria
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Inclusion: Individuals who can speak, read and understand English (or have a trusted individual to help with study procedures).
Exclusion:- Individuals who are less than 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 enroll but do not receive any dose of the vaccine.
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Supplementary Information
-
A random sample of emails of persons registering for vaccination at an Ontario center who provide their email and consent to be contacted for research in the target population age groups will be forwarded by the Ministry of Ontario to the study site. The study site in turn will forward the email blast electronically to the participants on the list directing them to the STOPCoV study website. Pamphlets and posters describing the study and providing the website and contact information will be made available at Toronto vaccine distribution centers, primary care offices, pharmacies and community organizations supporting vaccine uptake.
Sample Size
- Number of Participants
- 400
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | StopCoV - 30-50 year olds - Baseline |
|
2020 | Ongoing | |
| 1 | StopCoV - 30-50 year olds - eDiary |
|
2020 | Ongoing | |
| 2 | StopCoV - 30-50 year olds - 7 days post 1st vaccine dose |
|
|
2021 (March) | Ongoing |
| 3 | StopCoV - 30-50 year olds - 3 weeks post 1st vaccine dose |
|
|
2021 (March) | Ongoing |
| 4 | StopCoV - 30-50 year olds - Pre-2nd vaccine dose |
|
|
2021 (March) | Ongoing |
| 5 | StopCoV - 30-50 year olds - 2 weeks post 2nd vaccine dose |
|
|
2021 (April) | Ongoing |
| 6 | StopCoV - 30-50 year olds - 12 weeks post 2nd vaccine dose |
|
|
2021 (July) | Ongoing |
| 7 | StopCoV - 30-50 year olds - 24 weeks post 2nd vaccine dose |
|
|
2021 (October) | Ongoing |
| 8 | StopCoV - 30-50 year olds - 36 weeks post 2nd vaccine dose |
|
|
2022 (January) | Ongoing |
| 9 | StopCoV - 30-50 year olds - 48 weeks post 2nd vaccine dose |
|
|
2022 (April) | Ongoing |
| 10 | StopCoV - 30-50 year olds - Follow-up 1 |
|
2021 (April) | 2021 (April) | |
| 11 | StopCoV - 30-50 year olds - Follow-up 2 |
|
2021 (May) | 2021 (May) | |
| 12 | StopCoV - 30-50 year olds - Follow-up 3 |
|
2021 (June) | 2021 (June) | |
| 13 | StopCoV - 30-50 year olds - Follow-up 4 |
|
2021 (July) | 2021 (July) | |
| 14 | StopCoV - 30-50 year olds - Follow-up 5 |
|
2021 (August) | 2021 (August) | |
| 15 | StopCoV - 30-50 year olds - Follow-up 6 |
|
2021 (September) | 2021 (September) | |
| 16 | StopCoV - 30-50 year olds - Follow-up 7 |
|
2021 (October) | 2021 (October) | |
| 17 | StopCoV - 30-50 year olds - Follow-up 8 |
|
2021 (November) | 2021 (November) | |
| 18 | StopCoV - 30-50 year olds - Follow-up 9 |
|
2021 (December) | 2021 (December) | |
| 19 | StopCoV - 30-50 year olds - Follow-up 10 |
|
2022 (January) | 2022 (January) | |
| 20 | StopCoV - 30-50 year olds - Follow-up 11 |
|
2022 (February) | 2022 (February) | |
| 21 | StopCoV - 30-50 year olds - Follow-up 12 |
|
2022 (March) | 2022 (March) | |
| 22 | StopCoV - 30-50 year olds - Follow-up 13 |
|
2022 (April) | 2022 (April) |
StopCoV - 70 years and older
The population is composed of individuals that are 70 years and older that will receive or have received a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center.
Selection Criteria
- Minimum age
-
70
- Countries
-
- Canada
- Canadian Provinces
-
- Ontario
- Other Criteria
-
Inclusion: Individuals who can speak, read and understand English (or have a trusted individual to help with study procedures).
Exclusion:- Individuals who are less than < 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 will be excluded if they who enrol but do not receive any dose of the vaccine.
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Supplementary Information
-
A random sample of emails of persons registering for vaccination at an Ontario center who provide their email and consent to be contacted for research in the target population age groups will be forwarded by the Ministry of Ontario to the study site. The study site in turn will forward the email blast electronically to the participants on the list directing them to the STOPCoV study website. Participants were also recruited through three email blasts that were done through ZOOMER media to CARP- Canadian association of retired persons. Pamphlets and posters describing the study and providing the website and contact information will be made available at Toronto vaccine distribution centers, primary care offices, pharmacies and community organizations supporting vaccine uptake.
Sample Size
- Number of Participants
- 900
Data Collection Events
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-02-27T15:47:02.628