Individual Study / IMPACT-COVID

Immune Response after COVID-19 Vaccination during Maintenance Therapy in Immune-mediated Inflammatory Diseases: an Observational Cohort Study
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Immune Response after COVID-19 Vaccination during Maintenance Therapy in Immune-mediated Inflammatory Diseases: an Observational Cohort Study

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Datasets -
Variables -
Start Year
2021
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Members

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Investigators Contacts
  • Dr. Vinod Chandran
    University Health Network
  • Dr. Tania Watts
    University of Toronto
  • Dr. Mark Silverberg
    Lunenfeld-Tanenbaum Research Institute
  • Dr. Vincent Piguet
    University of Toronto
  • Dr. Vinod Chandran
    University Health Network

Design

Study design
Case-control
Follow Up
After baseline, participants are followed up at 2-4 weeks post dose 1; 2-4 weeks post dose 2; 3-4 months post dose 2 or just before dose 3; 2-4 weeks post dose 3; 3-4 months post dose 3 or just before dose 4; 2-4 weeks post dose 4 and 3-4 months post dose 4.

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
600
Number of Participants with Biological Samples
600

Access

Availability of data and biosamples

Possible Access to Data
Possible Access to Biosamples
Other
Yes
No
Not applicable
Don't know

Timeline

Populations

Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants with known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Healthy Controls - Pre-vaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Healthy Controls - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Healthy Controls - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Healthy Controls - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Healthy Controls - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Healthy Controls - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Healthy Controls - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Healthy Controls - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs and not on immunosuppressives are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - No Immunosuppressives - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - No Immunosuppressives - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - No Immunosuppressives - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - No Immunosuppressives - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - No Immunosuppressives - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - No Immunosuppressives - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - No Immunosuppressives - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - No Immunosuppressives - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with anti-TNF are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Anti-TNF - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Anti-TNF - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Anti-TNF - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Anti-TNF - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Anti-TNF - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Anti-TNF - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Anti-TNF - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Anti-TNF - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with anti-IL-17 are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Anti-IL-17 - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Anti-IL-17 - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Anti-IL-17 - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Anti-IL-17 - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Anti-IL-17 - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Anti-IL-17 - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Anti-IL-17 - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Anti-IL-17 - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with methotrexate or thiopurines monotherapy are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Methotrexate/Thiopurines - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Methotrexate/Thiopurines - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Methotrexate/Thiopurines - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Methotrexate/Thiopurines - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Methotrexate/Thiopurines - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Methotrexate/Thiopurines - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Methotrexate/Thiopurines - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Methotrexate/Thiopurines - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with a combination therapy of thiopurines or methotrexate plus anti- TNF are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Methotrexate/Thiopurines plus Anti-TNF - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with anti-IL-12/23 are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Anti-IL-12/23 - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Anti-IL-12/23 - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Anti-IL-12/23 - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Anti-IL-12/23 - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Anti-IL-12/23 - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Anti-IL-12/23 - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Anti-IL-12/23 - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Anti-IL-12/23 - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Toronto
Ethnic Origin
Health Status
  • Participants who have IMIDs being treated with anti-IL-23 are included.
    Participants who have known allergy to vaccine components are excluded.
Other Criteria
Participants who are going to be vaccinated against SARS-CoV-2 with the BNT162b2 mRNA (Pfizer) or 1273 mRNA (Moderna) vaccine are included.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of Participants

Number of Participants
75
Number of Participants with Biological Samples
75
Data Collection Events
# Name Description Start End
0 IMPACT-COVID - Anti-IL-23 - Prevaccination baseline Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness) and vaccination history ... 2021
1 IMPACT-COVID - Anti-IL-23 - 2-4 weeks post dose 1 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
2 IMPACT-COVID - Anti-IL-23 - 2-4 weeks post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
3 IMPACT-COVID - Anti-IL-23 - 3-4 months post dose 2 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
4 IMPACT-COVID - Anti-IL-23 - 2-4 weeks post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
5 IMPACT-COVID - Anti-IL-23 - 3-4 months post dose 3 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
6 IMPACT-COVID - Anti-IL-23 - 2-4 weeks post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021
7 IMPACT-COVID - Anti-IL-23 - 3-4 months post dose 4 Demographics (age, sex), weight, height, relevant past medical and surgical history, medication use, COVID-19 specific questions (positive test, suspected illness), vaccination history (including ... 2021

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
Labour force and retirement

Lifestyle and behaviours

Tobacco
Alcohol
Drugs

Perception of health, quality of life, development and functional limitations

Perception of health

Diseases

Certain infectious and parasitic diseases (A00-B99)
Endocrine, nutritional and metabolic diseases (E00-E90)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the skin and subcutaneous tissue (L00-L99)
Diseases of the musculoskeletal system and connective tissue (M00-M99)
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
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Physical measures and assessments

Anthropometry

Laboratory measures

Virology
Immunology

Physical environment

Biological exposure

Administrative information

Identifiers
Date and time-related information
Physical and cognitive measure and biosample-related information
Other administrative information