Toward Enhancing COVID-19 Vaccine Confidence among African Canadians: Sustainability of Immune Responses and Safety Profiles.
Networks
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Datasets
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Variables
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The overarching objective of the study is to generate COVID-19 vaccine immunogenicity data from racialized groups within COVID-19 hot zones in Ontario and other Canadian provinces. The primary focus is on Black Canadians, given data suggesting that they are disproportionately represented among COVID-19 cases and severe outcomes. It will determine the immune responses to vaccines and the sustainability of these responses over the duration of the study. It will also determine the factors that might influence vaccine responses among the study population. Vaccine surveillance for adverse events of special interest (AESIs) will be determined. The generation of safety data from racialized communities will be important in building vaccine confidence and reducing hesitancy in the future.
PRIMARY AIMS
* Aim 1: Humoral immunity. To determine the
antibody responses to the COVID-19 vaccines
among a population of Black Canadians (African,
Caribbean, North American) residing in geographic
areas with the highest rates of COVID-19 in order
to determine the extent to which this population is
vulnerable to infection and adverse outcomes.
Antibody responses will be as reflected by
immunoassays and neutralization assays.
* Aim 2: Cell-mediated Immunity. To
determine the extent to which serological
evidence of vaccine response is associated
with persistence of cell-mediated immunity
to vaccine antigen(s).
SECONDARY AIMS
* Aim 3: Impact of seasonal coronaviruses. To examine the potential impact of seasonal coronaviruses on COVID-19 vaccine-associated antibody responses.
* Aim 4: Vaccine surveillance (safety). To examine the safety profiles of vaccines (as reflected by Adverse Events of Special Interest) received by the study population, including those at highest risk of severe outcomes from COVID-19 (e.g., patients with Sickle Cell Disease and elderly patients with co-morbidities that are the most prevalent within the Black community).
- Start Year
- 2021
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Design
- Study design
- Cohort
- Follow Up
- Participants will be followed-up at up to 4 time points over 12 months depending on their COVID-19 vaccination status.
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 2,000
- Number of Participants with Biological Samples
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
The population is composed of children over 12 and adults who identify as African Canadian who reside in Ontario, Quebec, Nova Scotia and British Columbia.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Ethnic Origin
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- Participants identify as African Canadians
- Health Status
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- Exclusion criteria: Presence of symptomatic respiratory tract infection or other symptoms consistent with COVID-19 at the time of blood sampling, and known immunodeficiency, including HIV/AIDS patients with CD4 counts less than 500 per cubic mm.
- Other Criteria
- All ages which are eligible to receive the COVID-19 vaccine based on most updated eligibility criteria in the province.
Recruitment
- Sources of recruitment
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- General population
- Participants from existing studies
- General Population
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- Volunteer enrolment
- Selected sample
- Supplementary Information
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Participants will be recruited from 3 sources. * A COVID-19 seroprevalence study of Black and non-Black Canadians in COVID-19 hot spots in Ontario. These persons are enrolled through random sampling. * A random survey of person in predominantly Black neighbourhoods to identify those who were vaccinated but are not in our seroprevalence study. * Data from 8 combined cycles of the National Population Health Survey (1996-97) and the Canadian Community Health Survey (2001 through 2014).
- Participants from Existing Studies
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- Seroprevalence of SARS-CoV-2 among African Canadians: Clinical and Epidemiological Correlates
National Population Health Survey (1996-97)
Canadian Community Health Survey (2001 through 2014)
- Seroprevalence of SARS-CoV-2 among African Canadians: Clinical and Epidemiological Correlates
Number of Participants
- Number of Participants
- 1,500
- Number of Participants with Biological Samples
- 1,500
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
seroMARK-VR - Black Canadians - 0-30 days pre-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-04 | 2021-04 |
| 1 |
seroMARK-VR - Black Canadians - 4-6 weeks post-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-05 | 2021-05 |
| 2 |
seroMARK-VR - Black Canadians - 4-6 weeks post-dose 2
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-07 | 2021-07 |
| 3 |
seroMARK-VR - Black Canadians - 9-12 months post-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2022-01 | 2022-03 |
The population is composed of children over 12 and adults who identify as non-African Canadian who reside in Ontario, Quebec, Nova Scotia and British Columbia.
Selection Criteria
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Exclusion criteria: Presence of symptomatic respiratory tract infection or other symptoms consistent with COVID-19 at the time of blood sampling, and known immunodeficiency, including HIV/AIDS patients with CD4 counts less than 500 per cubic mm.
- Other Criteria
- All ages which are eligible to receive the COVID-19 vaccine based on most updated eligibility criteria in the province.
Recruitment
- Sources of recruitment
-
- General population
- Participants from existing studies
- General Population
-
- Volunteer enrolment
- Selected sample
- Supplementary Information
-
Participants will be recruited from 3 sources. * A COVID-19 seroprevalence study of Black and non-Black Canadians in COVID-19 hot spots in Ontario. These persons are enrolled through random sampling. * A random survey of person in predominantly Black neighbourhoods to identify those who were vaccinated but are not in our seroprevalence study. * Data from 8 combined cycles of the National Population Health Survey (1996-97) and the Canadian Community Health Survey (2001 through 2014).
- Participants from Existing Studies
-
- Seroprevalence of SARS-CoV-2 among African Canadians: Clinical and Epidemiological Correlates
National Population Health Survey (1996-97)
Canadian Community Health Survey (2001 through 2014)
- Seroprevalence of SARS-CoV-2 among African Canadians: Clinical and Epidemiological Correlates
Number of Participants
- Number of Participants
- 500
- Number of Participants with Biological Samples
- 500
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
seroMARK-VR - non-Black Canadians - 0-30 days pre-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-04 | 2021-04 |
| 1 |
seroMARK-VR - non-Black Canadians - 4-6 weeks post-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-05 | 2021-05 |
| 2 |
seroMARK-VR - non-Black Canadians - 4-6 weeks post-dose 2
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2021-07 | 2021-07 |
| 3 |
seroMARK-VR - non-Black Canadians - 9-12 months post-dose 1
|
Clinical data was collected including chronic medical conditions (e.g., chronic kidney disease, diabetes) and medications that might affect the immune responses to COVID-19 vaccines. The types of ... | 2022-01 | 2022-03 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Family and household structure
Education
Residence
Birthplace
Ethnicity, race and religion
Labour force and retirement
Income, possessions, and benefits
Other socio-demographic and economic characteristics
Lifestyle and behaviours
Tobacco
Breastfeeding
Transportation
Birth, pregnancy and reproductive health history
Pregnancy, delivery and birth
Diseases
Certain infectious and parasitic diseases (A00-B99)
Neoplasms (C00-D48)
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism (D50-D89)
Endocrine, nutritional and metabolic diseases (E00-E90)
Diseases of the nervous system (G00-G99)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the musculoskeletal system and connective tissue (M00-M99)
Diseases of the genitourinary system (N00-N99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Symptoms and signs involving the circulatory and respiratory systems (R00-R09)
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving the skin and subcutaneous tissue (R20-R23)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Non-pharmacological interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Death
Vital status
Physical measures and assessments
Anthropometry
Laboratory measures
Virology
Preschool, school and work life
Work life
Social environment and relationships
Social participation
Physical environment
Housing characteristics
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Other administrative information