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COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety
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COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety

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Datasets -
Variables -
Start Year
2021
End Year
2023
Supplementary Information
Substudy: Understanding COVID-19 vaccine confidence in people living with HIV in Canada: A pan-Canadian survey vaccine https://www.hivnet.ubc.ca/study/ctn-328-1-vaccine-confidence-in-hiv/
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Investigators Contacts
  • Dr. Aslam Anis
    CIHR Canadian HIV Trials Network
  • Dr. Cecilia Costiniuk
    McGill University Health Centre
  • Dr. Ann Burchell
    St. Michael’s Hospital
  • Dr. Curtis Cooper
    Ottawa Hospital Research Institute
  • Dr. Naveed Janjua
    BC Center for Disease Control
  • Dr. Abigail Kroch
    Ontario HIV Treatment Network
  • Dr. Aslam Anis
    CIHR Canadian HIV Trials Network
  • Dr. Judy Needham
    CIHR Canadian HIV Trials Network

Design

Study design
Other :
AIM 1: Cohort
AIM 2: Cohort and "test-negative" (TND)
Follow Up
AIM1 After the screening visit, participants of HIV-COV cohorts living with HIV (PLWH) are followed-up at 4 weeks after 1st dose, at 3 months, 6 months and 12 months after 2nd dose, and at 4 weeks, 6 months and 12 months after 3rd dose of COVID-19 vaccine. Controls are followed monthly after baseline. AIM2 Participants are compared within-group among people living with HIV (test-positive cases and test-negative controls with SARS-CoV-2) and to HIV-negative individuals.
Supplementary Information

Marker Paper

Costiniuk CT, Singer J, Langlois M, et al. CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study. BMJ Open 2021;11:e054208

PUBMED 34916326

Recruitment

Recruitment Target
  • Individuals

Number of Participants

Number of Participants
69,528
Number of Participants with Biological Samples
Supplementary Information
HIV-COV PLWH: 400 participants
HIV-COV Non-HIV: 1,032 participants
Derived PLWH: 30,143 participants
Derived Non-HIV: 29,495 participants
TND PLWH Cases: 1,164 participants
TND PLWH Controls: 7,294 participants

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
16
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are HIV-positive.
    Participants are excluded if they present signs or symptoms of active COVID-19 infection.
Other Criteria
Participants are excluded if they received 3 COVID-19 doses prior to enrolment.
Supplementary Information about selection criteria
The following group is prioritized for the study enrolment and contributes to at least to 20% of the HIV-COV PLWH recruitment (per category): * Older age (55 years and over), * Immune non-responders (CD4 T cell count less than 350 cells/mm3, CD4/CD8 less than 0.75 with undetectable viral load for at least 6 months), * With 2 or more comorbidities, and/or * HIV-positive “stable” (CD4 T cell counts equal to or more than 350 cells/mm3 with undetectable HIV viral load for at least 6 months, and a maximum of 1 comorbidity).

Recruitment

Sources of recruitment
  • General population
  • Specific population
General Population
  • Volunteer enrolment
Specific Population
  • Clinic patients
Supplementary Information
Participants are informed about the study through a recruitment flyer during routine physician visits to their HIV clinic and via established recruitment strategies through our community partners and the CIHR Canadian HIV Trials Network via webpages, email, and social media platforms. 100 HIV positive participants will be recruited from each of the 4 sites in Montreal, Ottawa, Toronto and Vancouver.

Number of Participants

Number of Participants
400
Number of Participants with Biological Samples
400
Supplementary Information about selection criteria
Data Collection Events
# Name Description Start End
0 COVAXHIV - HIV-COV PLWH - Screening Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-04 2022-01
1 COVAXHIV - HIV-COV PLWH - 4 weeks post dose 1 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2021-04 2022-02
2 COVAXHIV - HIV-COV PLWH - 3 months post dose 2 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2021-07
3 COVAXHIV - HIV-COV PLWH - 6 months post dose 2 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2021-10
4 COVAXHIV - HIV-COV PLWH - 4 weeks post dose 3 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2021-11
5 COVAXHIV - HIV-COV PLWH - 12 months post dose 2 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2022-04
6 COVAXHIV - HIV-COV PLWH - 6 months post dose 3 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2022-04
7 COVAXHIV - HIV-COV PLWH - 12 months post dose 3 Information on COVID-19 history and exposure, health behaviours, adverse events post-vaccination, concomitant medications and medication changes, symptoms of respiratory illness, and general ... 2022-10
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are HIV-negative, immunocompetent and generally in good health, with a history of COVID-19 infection and/or vaccination and/or at risk of exposure to SARS-CoV-2.
    Participants are excluded if they have immune-compromising conditions, post-COVID symptoms or on medication which suppresses the immune response.
Other Criteria
Supplementary Information about selection criteria
The Stop the Spread Ottawa project is an analysis of antibody neutralization efficiency and cellular immunity to SARS-CoV-2-positive individuals identified in a surveillance and convalescence survey of at-risk individuals.

Recruitment

Sources of recruitment
  • General population
  • Participants from existing studies
General Population
  • Volunteer enrolment
Participants from Existing Studies
  • Stop the Spread Ottawa research project

Number of Participants

Number of Participants
1,032
Number of Participants with Biological Samples
986
Supplementary Information about selection criteria
Data Collection Events
# Name Description Start End
0 COVAXHIV - HIV-COV Non-HIV - Baseline Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2020-10 2022-02
1 COVAXHIV - HIV-COV Non-HIV - Follow-up 1 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2020-11 2020-11
2 COVAXHIV - HIV-COV Non-HIV - Follow-up 2 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2020-12 2020-12
3 COVAXHIV - HIV-COV Non-HIV - Follow-up 3 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-01 2021-01
4 COVAXHIV - HIV-COV Non-HIV - Follow-up 4 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-02 2021-02
5 COVAXHIV - HIV-COV Non-HIV - Follow-up 5 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-03 2021-03
6 COVAXHIV - HIV-COV Non-HIV - Follow-up 6 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-04 2021-04
7 COVAXHIV - HIV-COV Non-HIV - Follow-up 7 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-05 2021-05
8 COVAXHIV - HIV-COV Non-HIV - Follow-up 8 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-06 2021-06
9 COVAXHIV - HIV-COV Non-HIV - Follow-up 9 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-07 2021-07
10 COVAXHIV - HIV-COV Non-HIV - Follow-up 10 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-08 2021-08
11 COVAXHIV - HIV-COV Non-HIV - Follow-up 11 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-09 2021-09
12 COVAXHIV - HIV-COV Non-HIV - Follow-up 12 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-10 2021-10
13 COVAXHIV - HIV-COV Non-HIV - Follow-up 13 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-11 2021-11
14 COVAXHIV - HIV-COV Non-HIV - Follow-up 14 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2021-12 2021-12
15 COVAXHIV - HIV-COV Non-HIV - Follow-up 15 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2022-01 2022-01
16 COVAXHIV - HIV-COV Non-HIV - Follow-up 16 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2022-02 2022-02
17 COVAXHIV - HIV-COV Non-HIV - Follow-up 17 Demographic information, COVID-19 history and exposure, health behaviours, medical history (any medical conditions, current medications including vaccinations in the past 12 months and all ... 2022-03
Selection Criteria
Minimum age
16
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are living with HIV.
Other Criteria
Participants are included if they are alive and registered for OHIP as of December 14th, 2020, and are community-dwelling adults (excludes LTC residents).

Recruitment

Sources of recruitment
  • Participants from existing studies
Supplementary Information
Participants are identified using two data sources at International Credential Evaluation Service (ICES): * ICES-derived validated algorithm that identifies people living with HIV * Linked data from the Ontario HIV Treatment Network (OHTN) Cohort Study (OCS). They are also identified from provincial administrative records.
Participants from Existing Studies
  • ON HIV Treatment Network Cohort Study

Number of Participants

Number of Participants
30,143
Number of Participants with Biological Samples
Supplementary Information about selection criteria
ON Cohort: 21,037 participants
BC Cohort:9,106 participants (6686 vaccinated and 2220 unvaccinated, 496 tested-positive with COVID-19)
Data Collection Event
Start Date
2022-03
Data sources
  • Administrative databases
Data sources - Administrative databases
  • Health databases
Selection Criteria
Minimum age
19
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are not living with HIV.
Other Criteria
Participants are included if they are alive and registered for OHIP as of December 14, 2020, and are community-dwelling adults (excludes LTC residents). For a subset of population (in the tested-negative design), they are included if they are tested for SARS-CoV-2 between December 14, 2020 to December 31, 2021.

Recruitment

Sources of recruitment
  • General population
General Population
  • Selected sample
Supplementary Information
Participants are identified from provincial administrative records.

Number of Participants

Number of Participants
29,495
Number of Participants with Biological Samples
Supplementary Information about selection criteria
Cohort: 21,037 participants
TND: 8,458 participants
Data Collection Event
Start Date
2022-03
Data sources
  • Administrative databases
Data sources - Administrative databases
  • Health databases
Selection Criteria
Minimum age
19
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are living with HIV and tested positive for COVID-19.
Other Criteria
Participants are included if they are alive and registered for OHIP as of December 14th, 2020, are community-dwelling adults (excludes LTC residents), and are tested for SARS-CoV-2 between December 14, 2020, and December 31, 2021.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients
Supplementary Information
Participants are identified from provincial administrative records.

Number of Participants

Number of Participants
1,164
Number of Participants with Biological Samples
Data Collection Event
Start Date
2022-02
Data sources
  • Administrative databases
Data sources - Administrative databases
  • Health databases
Selection Criteria
Minimum age
19
Newborns
Twins
Countries
  • Canada
Territory
Ethnic Origin
Health Status
  • Participants are included if they are living with HIV and tested negative for COVID-19.
Other Criteria
Participants are included if they are alive and registered for OHIP as of December 14th, 2020, are community-dwelling adults (excludes LTC residents), and are tested for SARS-CoV-2 between December 14, 2020, and December 31, 2021.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients
Supplementary Information
Participants are identified from provincial administrative records.

Number of Participants

Number of Participants
7,294
Number of Participants with Biological Samples
Data Collection Event
Start Date
2022-02
Data sources
  • Administrative databases
Data sources - Administrative databases
  • Health databases

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
Citizenship and immigrant status
Ethnicity, race and religion
Labour force and retirement
Income, possessions, and benefits
Other socio-demographic and economic characteristics

Lifestyle and behaviours

Tobacco
Drugs
Sexual behaviours and orientation
Leisure activities

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 genitourinary system (N00-N99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
External causes of morbidity and mortality (V01-Y98)
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

Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions

Health and community care services utilization

Visits to health professionals
Hospitalizations

Death

Vital status
Cause of death

Physical measures and assessments

Anthropometry

Laboratory measures

Hematology
Virology
Genomics

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
Data and sample collection center-related information
Other administrative information