Integrating Longitudinal Epidemiologic, Virologic and Immunologic Analyses to Understand COVID-19 Immunity and Infection Outcomes in Long Term Care
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.
Overview
- Acronym
- ILEVIA
- Investigators
-
- Contacts
-
General Design
- Study design
- Cohort
- Start - End Year
- 2020 - 2022
- General Information on Follow Up (profile, frequency)
-
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.
- Recruitment Target
-
- Individuals
- Number of Participants
- 153
- Number of Participants with Biological Samples
- 153
- Supplementary Information
-
https://www.medrxiv.org/content/10.1101/2021.03.17.21253773v1
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Data will be available by the end of the study
Timeline
Populations
ILEVIA - LTC Elderly unvaccinated
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
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Sources of Recruitment
- Specific Population
-
- Other specific population : LTC Residents
- 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.
Sample Size
- Number of Participants
- 17
- Number of Participants with Biological Samples
- 17
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - LTC Elderly unvaccinated - Visit 1 |
|
|
2020 (November) | Ongoing |
| 1 | ILEVIA - LTC Elderly unvaccinated - Visit 2 |
|
|
2021 (January) | Ongoing |
| 2 | ILEVIA - LTC Elderly unvaccinated - Visit 2A |
|
|
2021 (March) | Ongoing |
| 3 | ILEVIA - LTC Elderly unvaccinated - Visit 3 |
|
|
2021 (March) | Ongoing |
| 4 | ILEVIA - LTC Elderly unvaccinated - Visit 4 |
|
|
2021 (May) | Ongoing |
| 5 | ILEVIA - LTC Elderly unvaccinated - Visit 5 |
|
|
2021 (August) | Ongoing |
| 6 | ILEVIA - LTC Elderly unvaccinated - Visit 6 |
|
|
2022 (February) | Ongoing |
ILEVIA - LTC Elderly vaccinated
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
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- 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.
Sources of Recruitment
- 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.
Sample Size
- Number of Participants
- 7
- Number of Participants with Biological Samples
- 7
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - Elderly vaccinated - Visit 1 |
|
|
2021 (March) | Ongoing |
| 1 | ILEVIA - Elderly vaccinated - Visit 2 |
|
|
2021 (June) | Ongoing |
| 2 | ILEVIA - Elderly vaccinated - Visit 3 |
|
|
2021 (December) | Ongoing |
ILEVIA - Community Elderly unvaccinated
The population is composed of seniors living in the community in Vancouver, British Columbia, who did not receive COVID-19 vaccines.
Selection Criteria
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Sources of Recruitment
- Specific Population
-
- Other specific population : Seniors in the community
Sample Size
- Number of Participants
- 38
- Number of Participants with Biological Samples
- 38
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - Community Elderly unvaccinated - Visit 1 |
|
|
2020 (November) | Ongoing |
| 1 | ILEVIA - Community Elderly unvaccinated - Visit 2 |
|
|
2021 (January) | Ongoing |
| 2 | ILEVIA - Community Elderly unvaccinated - Visit 2A |
|
|
2021 (March) | Ongoing |
| 3 | ILEVIA - Community Elderly unvaccinated - Visit 3 |
|
|
2021 (March) | Ongoing |
| 4 | ILEVIA - Community Elderly unvaccinated - Visit 4 |
|
|
2021 (May) | Ongoing |
| 5 | ILEVIA - Community Elderly unvaccinated - Visit 5 |
|
|
2021 (August) | Ongoing |
| 6 | ILEVIA - Community Elderly unvaccinated - Visit 6 |
|
|
2022 (February) | Ongoing |
ILEVIA - Community Elderly vaccinated
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
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- 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.
Sources of Recruitment
- Specific Population
-
- Other specific population : Seniors in the community
Sample Size
- Number of Participants
- 2
- Number of Participants with Biological Samples
- 2
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - Community Elderly vaccinated - Visit 1 |
|
|
2021 (March) | Ongoing |
| 1 | ILEVIA - Community Elderly vaccinated - Visit 2 |
|
|
2021 (June) | Ongoing |
| 2 | ILEVIA - Community Elderly vaccinated - Visit 3 |
|
|
2021 (December) | Ongoing |
ILEVIA - Staff unvaccinated
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
-
18
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- Health Status
-
- Prior infection with SARS-CoV-2
- Other Criteria
- Exclusion: Individuals who have already received a COVID-19 vaccine dose
Sources of Recruitment
- Specific Population
-
- Members of an association
- 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.
Sample Size
- Number of Participants
- 88
- Number of Participants with Biological Samples
- 88
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - Staff unvaccinated - Visit 1 |
|
|
2020 (November) | Ongoing |
| 1 | ILEVIA - Staff unvaccinated - Visit 2 |
|
|
2021 (January) | Ongoing |
| 2 | ILEVIA - Staff unvaccinated - Visit 2A |
|
|
2021 (March) | Ongoing |
| 3 | ILEVIA - Staff unvaccinated - Visit 3 |
|
|
2021 (March) | Ongoing |
| 4 | ILEVIA - Staff unvaccinated - Visit 4 |
|
|
2021 (May) | Ongoing |
| 5 | ILEVIA - Staff unvaccinated - Visit 5 |
|
|
2021 (August) | Ongoing |
| 6 | ILEVIA - Staff unvaccinated - Visit 6 |
|
|
2022 (February) | Ongoing |
ILEVIA - Staff vaccinated
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
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Territory
- Vancouver
- 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.
Sources of Recruitment
- 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.
Sample Size
- Number of Participants
- 1
- Number of Participants with Biological Samples
- 1
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | ILEVIA - Staff vaccinated - Visit 1 |
|
|
2021 (March) | Ongoing |
| 1 | ILEVIA - Staff vaccinated - Visit 2 |
|
|
2021 (June) | Ongoing |
| 2 | ILEVIA - Staff vaccinated - Visit 3 |
|
|
2021 (December) | Ongoing |
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: 2024-02-27T14:25:02.942