Integrating Longitudinal Epidemiologic, Virologic and Immunologic Analyses to Understand COVID-19 Immunity and Infection Outcomes in Long Term Care
Networks
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Datasets
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Variables
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The primary objectives of this study are to:
* Assess general features of innate and adaptive immune function in residents of long-term care (LTC) facilities and health care workers.
* Characterize SARS-CoV-2 immune reactivity prior to infection or COVID-19 vaccination.
* Examine the strength and durability of immune responses to SARS-CoV-2 infection or COVID -19 vaccination.
The secondary objectives of this study are to:
* Identify socio-demographic, clinical and biological correlates of antiviral immunity to inform public health.
* Assess vaccine willingness/hesitation in the study population.
* Support virologic and immunologic investigations of COVID-19 should an outbreak occur in the presence or absence of vaccination.
- Start Year
- 2020
- End Year
- 2022
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Follow Up
- Participants are followed for up to 12 months to assess the strength and durability of immune responses to COVID-19 vaccination. Unvaccinated participants complete six study visits: before the first dose of vaccine, one month after the first dose, one month, three months, six months and 12 months (optional visit) post-second dose of vaccination. Unvaccinated participants with an extended dose interval (4 months instead of 42 days) will be invited to complete one additional study visit as close as possible prior to their second vaccine dose. Vaccinated participants completed three visits: one month, six months and 12 months after the second dose.
- Supplementary Information
- https://www.medrxiv.org/content/10.1101/2021.03.17.21253773v1
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 153
- Number of Participants with Biological Samples
- 153
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Supplementary Information
Data will be available by the end of the study
Timeline
Populations
The population is composed of residents of long-term care (LTC) facilities in Vancouver, British Columbia, who did not receive COVID-19 vaccines.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Vancouver
- Ethnic Origin
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- Health Status
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- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Other specific population : LTC Residents
- Supplementary Information
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Participating residents came from six LTC (including assisted living) facilities affiliated with Providence Health Care which are: Holy Family Hospital; Youville Residence (excluding its mental health unit); St. Vincent's-Honoria Conway-Heather (assisted living); St. Vincent's-Brock Fahrni; Mount Saint Joseph Hospital; and St. Vincent's-Langara.
Number of Participants
- Number of Participants
- 17
- Number of Participants with Biological Samples
- 17
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - LTC Elderly unvaccinated - Visit 1
|
Visit 1 (baseline) took place before vaccination to assess baseline immunity. Information on demographics (age, sex, gender, ethnicity/indigenous ancestry, postal code, education, household ... | 2020-11 | |
| 1 |
ILEVIA - LTC Elderly unvaccinated - Visit 2
|
Visit 2 took place one month after the first dose of vaccine to assess interim vaccine immunity. Information on demographics (age), health status (known Covid-19 infection, testing, ... | 2021-01 | |
| 2 |
ILEVIA - LTC Elderly unvaccinated - Visit 2A
|
Visit 2A took place 3-3,5 month after the first dose of vaccine to assess interim vaccine immunity in participants with extended dose intervals. Information on demographics (age), health status ... | 2021-03 | |
| 3 |
ILEVIA - LTC Elderly unvaccinated - Visit 3
|
Visit 3 took place 1 month after the second dose of vaccine to assess peak immunity. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-03 | |
| 4 |
ILEVIA - LTC Elderly unvaccinated - Visit 4
|
Visit 4 took place 3 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-05 | |
| 5 |
ILEVIA - LTC Elderly unvaccinated - Visit 5
|
Visit 5 took place 6 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-08 | |
| 6 |
ILEVIA - LTC Elderly unvaccinated - Visit 6
|
Visit 6 took place 12 months after the second dose of vacce to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2022-02 |
The population is composed of residents of long-term care (LTC) facilities in Vancouver, British Columbia, who have received the second dose of the COVID-19 vaccine no longer than one month prior enrolment. Vaccine was available for LTC residents from December/January 2020.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
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- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received their second COVID-19 vaccine dose more than one month prior to enrolment.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : LTC Residents and seniors in the community
- Supplementary Information
-
Participating residents came from six LTC (including assisted living) facilities affiliated with Providence Health Care which are: Holy Family Hospital; Youville Residence (excluding its mental health unit); St. Vincent's-Honoria Conway-Heather (assisted living); St. Vincent's-Brock Fahrni; Mount Saint Joseph Hospital; and St. Vincent's-Langara.
Number of Participants
- Number of Participants
- 7
- Number of Participants with Biological Samples
- 7
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - Elderly vaccinated - Visit 1
|
Visit 1 took place one month after the second dose of vaccine to assess peak immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information includes ... | 2021-03 | |
| 1 |
ILEVIA - Elderly vaccinated - Visit 2
|
Visit 2 took place six months after the first dose of vaccine in order to assess durability immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information ... | 2021-06 | |
| 2 |
ILEVIA - Elderly vaccinated - Visit 3
|
Visit 3 took place 12 months after the first dose of vaccine in order to assess durability immunity. Information on demographics (age), health status (known Covid-19 infection, testing, ... | 2021-12 |
The population is composed of seniors living in the community in Vancouver, British Columbia, who did not receive COVID-19 vaccines.
Selection Criteria
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Seniors in the community
Number of Participants
- Number of Participants
- 38
- Number of Participants with Biological Samples
- 38
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - Community Elderly unvaccinated - Visit 1
|
Visit 1 (baseline) took place before vaccination to assess baseline immunity. Information on demographics (age, sex, gender, ethnicity/indigenous ancestry, postal code, education, household ... | 2020-11 | |
| 1 |
ILEVIA - Community Elderly unvaccinated - Visit 2
|
Visit 2 took place one month after the first dose of vaccine to assess interim vaccine immunity. Information on demographics (age), health status (known Covid-19 infection, testing, ... | 2021-01 | |
| 2 |
ILEVIA - Community Elderly unvaccinated - Visit 2A
|
Visit 2A took place 3-3,5 month after the first dose of vaccine to assess interim vaccine immunity in participants with extended dose intervals. Information on demographics (age), health status ... | 2021-03 | |
| 3 |
ILEVIA - Community Elderly unvaccinated - Visit 3
|
Visit 3 took place 1 month after the second dose of vaccine to assess peak immunity. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-03 | |
| 4 |
ILEVIA - Community Elderly unvaccinated - Visit 4
|
Visit 4 took place 3 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, ... |
2021-05 | |
| 5 |
ILEVIA - Community Elderly unvaccinated - Visit 5
|
Visit 5 took place 6 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-08 | |
| 6 |
ILEVIA - Community Elderly unvaccinated - Visit 6
|
Visit 6 took place 12 months after the second dose of vacce to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2022-02 |
The population is composed of seniors living in the community iin Vancouver, British Columbia, who have received the second dose of the COVID-19 vaccine no longer than one month prior enrolment. Vaccine was available for seniors in the community around March/April 2021.
Selection Criteria
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received their second COVID-19 vaccine dose more than one month prior to enrolment.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : Seniors in the community
Number of Participants
- Number of Participants
- 2
- Number of Participants with Biological Samples
- 2
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - Community Elderly vaccinated - Visit 1
|
Visit 1 took place one month after the second dose of vaccine to assess peak immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information includes ... | 2021-03 | |
| 1 |
ILEVIA - Community Elderly vaccinated - Visit 2
|
Visit 2 took place six months after the first dose of vaccine in order to assess durability immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information ... | 2021-06 | |
| 2 |
ILEVIA - Community Elderly vaccinated - Visit 3
|
Visit 3 took place 12 months after the first dose of vaccine in order to assess durability immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information ... | 2021-12 |
The population is composed of health care workers in long-term care (LTC) facilities affiliated with Providence Health Care (PHC), located in Vancouver, and who have documented prior infection with SARS-CoV-2 (i.e. outbreak survivors) and/or those who are expected to be offered a COVID-19 vaccine because of their membership in a priority group.
Selection Criteria
- Minimum age
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18
- Newborns
- Twins
- Countries
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- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
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- Members of an association
- Other specific population : LTC health care workers
- Supplementary Information
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Strategies of recruitment included hanging posters, Providence Health Care (PHC) email lists and web-based communications.
Number of Participants
- Number of Participants
- 88
- Number of Participants with Biological Samples
- 88
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - Staff unvaccinated - Visit 1
|
Visit 1 (baseline) took place before vaccination to assess baseline immunity. Information on demographics (age, sex, gender, ethnicity/indigenous ancestry, postal code, education, household ... | 2020-11 | |
| 1 |
ILEVIA - Staff unvaccinated - Visit 2
|
Visit 2 took place one month after the first dose of vaccine to assess interim vaccine immunity. Information on demographics (age), health status (known Covid-19 infection, testing, ... | 2021-01 | |
| 2 |
ILEVIA - Staff unvaccinated - Visit 2A
|
Visit 2A took place 3-3,5 month after the first dose of vaccine to assess interim vaccine immunity in participants with extended dose intervals. Information on demographics (age), health status ... | 2021-03 | |
| 3 |
ILEVIA - Staff unvaccinated - Visit 3
|
Visit 3 took place 1 month after the second dose of vaccine to assess peak immunity. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-03 | |
| 4 |
ILEVIA - Staff unvaccinated - Visit 4
|
Visit 4 took place 3 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-05 | |
| 5 |
ILEVIA - Staff unvaccinated - Visit 5
|
Visit 5 took place 6 months after the second dose of vaccine to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2021-08 | |
| 6 |
ILEVIA - Staff unvaccinated - Visit 6
|
Visit 6 took place 12 months after the second dose of vacce to assess immunity durability. Information on demographics (age), health status (known Covid-19 infection, testing, hospitalization; ... | 2022-02 |
The population is composed of health care workers in long-term care (LTC) facilities affiliated with Providence Health Care (PHC), located in Vancouver, and who have documented prior infection with SARS-CoV-2 (i.e. outbreak survivors) and have received the second dose of the COVID-19 vaccine no longer than one month prior enrolment.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Vancouver
- Ethnic Origin
-
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received their second COVID-19 vaccine dose more than one month prior to enrolment.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Other specific population : LTC health care workers
- Supplementary Information
-
Strategies of recruitment included hanging posters, Providence Health Care (PHC) email lists and web-based communications.
Number of Participants
- Number of Participants
- 1
- Number of Participants with Biological Samples
- 1
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
ILEVIA - Staff vaccinated - Visit 1
|
Visit 1 took place one month after the second dose of vaccine to assess peak immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information includes ... | 2021-03 | |
| 1 |
ILEVIA - Staff vaccinated - Visit 2
|
Visit 2 took place six months after the first dose of vaccine in order to assess durability immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information ... | 2021-06 | |
| 2 |
ILEVIA - Staff vaccinated - Visit 3
|
Visit 3 took place 12 months after the first dose of vaccine in order to assess durability immunity. The survey questionnaire is modeled on the CITF core elements survey. Collected information ... | 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
Lifestyle and behaviours
Tobacco
Leisure activities
Perception of health, quality of life, development and functional limitations
Perception of health
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 respiratory system (J00-J99)
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
Surgical interventions
Radiological interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Physical measures and assessments
Anthropometry
Laboratory measures
Virology
Immunology
Social environment and relationships
Social participation
Physical environment
Housing characteristics
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Other administrative information