Evaluating the Safety and Immunogenicity of SARS-CoV-2 Vaccines among Underserved Urban Populations with Intersecting Risk Factors for COVID-19 Morbidity and Mortality: A Pooled Analysis of Three Prospective Cohort Studies in Vancouver, Canada
Networks
-
Datasets
-
Variables
-
The purpose of this study is to evaluate the uptake, safety, and effectiveness of SARS-CoV-2 vaccines among members of marginalized urban populations in Vancouver, Canada.
The objectives of this study are to:
1. Estimate rates of SARS-CoV-2 vaccination and adherence to vaccine protocols (e.g., receipt of second vaccine dose within recommended time period);
2. Identify factors (e.g., vaccine knowledge/attitudes; homelessness) promoting or inhibiting vaccine uptake and adherence to vaccine protocols;
3. Investigate the immunogenicity of SARS-CoV-2 vaccines and compare immunogenicity across behavioural (e.g., opioid use), social/structural (e.g., housing status), and clinical (e.g., HIV-positive) strata;
4. Assess the durability of SARS-CoV-2-specific immune response at two, four, and six months post-vaccination;
5. Document and characterize adverse events and serious adverse events following vaccination across subgroups at increased risk of COVID-19 morbidity and mortality (e.g., older participants; people with substance use disorders).
- Start Year
- 2021
- End Year
- 2022
Visit SIC19VUUP
| Investigators | Contacts |
|---|---|
|
|
Design
- Study design
- Cohort
- Follow Up
- Participants were followed-up at 2, 4 and 6 months after vaccination.
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 275
- 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 individuals who are 18 years old or older, HIV negative, past-30-day injection drug use, and zero, partially, or fully vaccinated against COVID-19, from the Vancouver Injection Drug Users Study (VIDUS).
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- HIV negative
- Other Criteria
- past-30-day injection drug use
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- Participants from Existing Studies
-
- the Vancouver Injection Drug Users Study (VIDUS)
Number of Participants
- Number of Participants
- 101
- Number of Participants with Biological Samples
- 101
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
SIC19VUUP - VIDUS - Baseline
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-06 | 2021-06 |
| 1 |
SIC19VUUP - VIDUS - 2 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-08 | 2021-08 |
| 2 |
SIC19VUUP - VIDUS - 4 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-10 | 2021-10 |
| 3 |
SIC19VUUP - VIDUS - 6 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-12 | 2021-12 |
The population is composed of individuals who are 18 years old or older, HIV seropositive, past-30-day injection or non-injection drug use, and zero, partially, or fully vaccinated against COVID-19, from the AIDS Care Cohort to evaluate Exposure to Survival Services (ACCESS).
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- HIV seropositive
- Other Criteria
- past-30-day injection or non-injection drug use
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- Participants from Existing Studies
-
- AIDS Care Cohort to evaluate Exposure to Survival Services (ACCESS)
Number of Participants
- Number of Participants
- 97
- Number of Participants with Biological Samples
- 97
- Supplementary Information about selection criteria
- 54 participants (50% HIV-positive) will provide venous blood samples in addition to dried blood spot samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
SIC19VUUP - ACCESS - Baseline
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-06 | 2021-06 |
| 1 |
SIC19VUUP - ACCESS - 2 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-08 | 2021-08 |
| 2 |
SIC19VUUP - ACCESS - 4 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-10 | 2021-10 |
| 3 |
SIC19VUUP - ACCESS - 6 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-12 | 2021-12 |
The population is composed of individuals who are between 14 and 26 years old, who are street-involved (precariously housed, homeless), who past-30-day injection drug use, and zero, partially, or fully vaccinated against COVID-19, from the VAt-Risk Youth Study (ARYS).
Selection Criteria
- Minimum age
-
14
- Maximum age
-
26
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- street-involved (precariously housed, homeless), past-30-day injection or non-injection drug use
Recruitment
- Sources of recruitment
-
- Participants from existing studies
- Participants from Existing Studies
-
- At-Risk Youth Study (ARYS)
Number of Participants
- Number of Participants
- 77
- Number of Participants with Biological Samples
- 77
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
SIC19VUUP - ARYS - Baseline
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-06 | 2021-06 |
| 1 |
SIC19VUUP - ARYS - 2 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-08 | 2021-08 |
| 2 |
SIC19VUUP - ARYS - 4 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-10 | 2021-10 |
| 3 |
SIC19VUUP - ARYS - 6 months post vaccine
|
Information was collected about sociodemographic data, health history, experiences related to COVID-19 and vaccination uptake, substance use patterns. A blood sample was collected. | 2021-12 | 2021-12 |
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
Ethnicity, race and religion
Labour force and retirement
Income, possessions, and benefits
Lifestyle and behaviours
Tobacco
Alcohol
Drugs
Leisure activities
Perception of health, quality of life, development and functional limitations
Quality of life
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)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
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 nervous and musculoskeletal systems (R25-R29)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Posology and protocol of administration
Non-pharmacological interventions
Educational and health promotion interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Community and social care
Physical measures and assessments
Anthropometry
Life events, life plans, beliefs and values
Life events
Beliefs and values
Social environment and relationships
Social participation
Physical environment
Housing characteristics
Workplace characteristics
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Other administrative information