PRospective Evaluation of COVID-19 Vaccine in Transplant Recipients: A National Strategy
Networks
-
Datasets
-
Variables
-
The objectives of this study are:
* To assess the immunogenicity and safety of the COVID-19 vaccines by evaluating IgG antibody response levels against the receptor binding domain (anti-RBD) of the COVID-19 spike protein. Further immunological responses, such as neutralizing antibodies and CD4+ and CD8+ T cell-mediated immunity are also being evaluated.
* To develop a national safety surveillance system for COVID-19 vaccinations amongst transplant recipients.
* To coordinate the efforts of national and provincial organizations involved in public health and vaccination research to share current and emerging data.
* To build a lasting knowledge transfer platform to rapidly disseminate the research results to patient partners and public health agencies.
- Start Year
- 2021
- End Year
- 2023
- Supplementary Information
Visit PREVenT-COVID
| Investigators | Contacts |
|---|---|
|
|
Design
- Study design
- Cohort
- Follow Up
- Participants are followed once pre-COVID-19 vaccination, 3 to 6 weeks after any vaccine dose, and twice after the first dose at 6 and 12 months.
Marker Paper
Ferreira VH, Ierullo M, Mavandadnejad F, et al,. Omicron BA.4/5 Neutralization and T-Cell Responses in Organ Transplant Recipients After Booster Messenger RNA Vaccine: A Multicenter Cohort Study. Clin Infect Dis. 2023 Jul 26;77(2):229-236. doi: 10.1093/cid/ciad175.
PUBMED 36975097
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 900
- Number of Participants with Biological Samples
- Supplementary Information
-
Adult Solid Organ Transplant Recipients: 450 participants
Pediatric Solid Organ Transplant Recipients: 50 participants
Adult Hematopoietic Stem Cell Transplant Recipients: 100 participants
Pediatric Hematopoietic Stem Cell Transplant Recipients: 50 participants
Adult Healthy Controls: 200
Pediatric Healthy Controls: 50 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
The population is composed of adults solid organ transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from seven transplant centers: University Health Network, Université de Montréal, Hôpital Maisonneuve-Rosemont, Université Laval, London Health Sciences Centre, University of Alberta, and Vancouver General Hospital.
Number of Participants
- Number of Participants
- 450
- Number of Participants with Biological Samples
- Supplementary Information about selection criteria
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Adult Solid Organ Transplant Recipients - Pre-vaccination
|
Information is collected about age, sex, transplant type, time since transplant, immunosuppressant regimes, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Adult Solid Organ Transplant Recipients - 3 to 6 weeks post-vaccination
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 4 |
PREVenT-COVID - Adult Solid Organ Transplant Recipients - 6 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 5 |
PREVenT-COVID - Adult Solid Organ Transplant Recipients - 12 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
The population is composed of pediatric solid organ transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Maximum age
-
17
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from nine transplant centers: University Health Network, Université de Montréal, Hôpital Maisonneuve-Rosemont, Université Laval, London Health Sciences Centre, University of Alberta, Vancouver General Hospital, Hospital for Sick Children, and the BC Children's Hospital.
Number of Participants
- Number of Participants
- 50
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Pediatric Solid Organ Transplant Recipients - Pre-vaccination
|
Information is collected about age, sex, transplant type, time since transplant, immunosuppressant regimes, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Pediatric Solid Organ Transplant Recipients - 3 to 6 weeks post-vaccination
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 4 |
PREVenT-COVID - Pediatric Solid Organ Transplant Recipients - 6 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 5 |
PREVenT-COVID - Pediatric Solid Organ Transplant Recipients - 12 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
The population is composed of adult hematopoietic stem cell transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from seven transplant centers: University Health Network, Université de Montréal, Hôpital Maisonneuve-Rosemont, Université Laval, London Health Sciences Centre, University of Alberta, and Vancouver General Hospital.
Number of Participants
- Number of Participants
- 100
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Adult Hematopoietic Stem Cell Transplant Recipients - Pre-vaccination
|
Information is collected about age, sex, transplant type, time since transplant, immunosuppressant regimes, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Adult Hematopoietic Stem Cell Transplant Recipients - 3 to 6 weeks post-vaccination
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 4 |
PREVenT-COVID - Adult Hematopoietic Stem Cell Transplant Recipients - 6 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 5 |
PREVenT-COVID - Adult Hematopoietic Stem Cell Transplant Recipients - 12 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
The population is composed of pediatric hematopoietic stem cell transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Maximum age
-
17
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- Specific population
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are recruited from nine transplant centers: University Health Network, Université de Montréal, Hôpital Maisonneuve-Rosemont, Université Laval, London Health Sciences Centre, University of Alberta, Vancouver General Hospital, Hospital for Sick Children, and the BC Children's Hospital.
Number of Participants
- Number of Participants
- 50
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Pediatric Hematopoietic Stem CellTransplant Recipients - Pre-vaccination
|
Information is collected about age, sex, transplant type, time since transplant, immunosuppressant regimes, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Pediatric Hematopoietic Stem CellTransplant Recipients - 3 to 6 weeks post-vaccination
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 4 |
PREVenT-COVID - Pediatric Hematopoietic Stem CellTransplant Recipients - 6 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 5 |
PREVenT-COVID - Pediatric Hematopoietic Stem CellTransplant Recipients - 12 months post-dose 1
|
Information is collected about time since transplant, immunosuppressant regimes, comorbidities, and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
The population is composed of adult healthy individuals who are not transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Minimum age
-
18
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
Number of Participants
- Number of Participants
- 200
- Number of Participants with Biological Samples
- Supplementary Information about selection criteria
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Adult Healthy Controls - Pre-vaccination
|
Information is collected about age, sex, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Adult Healthy Controls - 3 to 6 weeks post-vaccination
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 3 |
PREVenT-COVID - Adult Healthy Controls - 6 months post-dose 1
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 4 |
PREVenT-COVID - Adult Healthy Controls - 12 months post-dose 1
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
The population is composed of healthy children who are not transplant recipients from Alberta, British Columbia, Ontario and Quebec.
Selection Criteria
- Maximum age
-
17
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Other Criteria
- Inclusion: Not yet vaccinated or received vaccine within the last 7 days.
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
Number of Participants
- Number of Participants
- 50
- Number of Participants with Biological Samples
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PREVenT-COVID - Pediatric Healthy Controls - Pre-vaccination
|
Information is collected about age, sex, and comorbidities. Blood samples are collected. | 2021-03 | 2023-03 |
| 1 |
PREVenT-COVID - Pediatric Healthy Controls - 3 to 6 weeks post-vaccination
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-03 | 2023-03 |
| 4 |
PREVenT-COVID - Pediatric Healthy Controls - 6 months post-dose 1
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2021-09 | 2023-03 |
| 5 |
PREVenT-COVID - Pediatric Healthy Controls - 12 months post-dose 1
|
Information is collected about comorbidities and adverse events from the COVID-19 vaccine. Blood samples are collected. | 2022-03 | 2023-03 |
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
Ethnicity, race and religion
Labour force and retirement
Lifestyle and behaviours
Tobacco
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 digestive system (K00-K93)
Diseases of the genitourinary system (N00-N99)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Medication and supplements
Medication and supplement intake
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
Preschool, school and work life
Work life
Physical environment
Housing characteristics
Administrative information
Date and time-related information
Questionnaire and interview-related information