COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety
The overarching goal of this study is to inform COVID-19 immunization guidelines for people living with HIV (PLWH).
AIM1
The first aim of this study is to compare the immunogenicity of COVID-19 vaccines among PLWH compared to people who are HIV-negative.
The objectives related to this aim are:
**Primary objective**
* To assess SARS-CoV-2-specific antibodies at 6 months following second-dose vaccination.
**Secondary objectives**
* To assess SARS-CoV-2-specific antibody neutralization capacity at 6 months following second-dose vaccination;
* To evaluate the durability of antibody response 12 months following third-dose vaccination;
* To assess whether SARS-CoV-2-specific antibody titers and neutralization capacity differ 6-months post-second vaccine dose from 6 months post-third vaccine dose and whether the relationship between response at the two time points is affected by HIV status; and
* To determine the safety and tolerability of COVID-19 vaccines in PLWH based on local or systemic adverse events following the first, second, or third injections.
AIM2
The second aim of this study is to estimate COVID-19 vaccine effectiveness (VE) among PLWH compared with people who are HIV-negative.
The objectives related to this aim are:
**Primary objective**
* To estimate VE against laboratory-confirmed infection with SARS-CoV-2.
**Secondary objectives**
* To estimate VE against hospitalization due to COVID-19 among laboratory-confirmed cases;
* To explore heterogeneity in VE according to sex, age, socioeconomic status, comorbidities, and HIV immune status.
Overview
- Acronym
- COVAXHIV
- Website
- COVAXHIV
- Investigators
-
- Contacts
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General Design
- Study design
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Other :
AIM 1: Cohort
AIM 2: Cohort and "test-negative" (TND) - Start - End Year
- 2021 - 2023
- General Information on Follow Up (profile, frequency)
-
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.
- Recruitment Target
-
- Individuals
- Number of Participants
- 69,528
- Supplementary information about number of participants
-
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 |
|
Marker Papers
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 34916326Supplementary 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/
Timeline
Populations
COVAXHIV - HIV-COV PLWH
The population is composed of individuals 16 years of age and older, who are HIV-positive and who are receiving a COVID-19 vaccination or have received 1 or 2 doses of a COVID-19 vaccine.
Selection Criteria
- Minimum age
-
16
- Countries
-
- Canada
- Canadian Provinces
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- British Columbia
- Ontario
- Quebec
- Health Status
-
- Participants are included if they are HIV-positive.
Participants are excluded if they present signs or symptoms of active COVID-19 infection.
- Participants are included if they are HIV-positive.
- 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).
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Specific Population
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- Clinic patients
- Supplementary Information
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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.
Sample Size
- Number of Participants
- 400
- Number of Participants with Biological Samples
- 400
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - HIV-COV PLWH - Screening |
|
|
2021 (April) | 2022 (January) |
| 1 | COVAXHIV - HIV-COV PLWH - 4 weeks post dose 1 |
|
|
2021 (April) | 2022 (February) |
| 2 | COVAXHIV - HIV-COV PLWH - 3 months post dose 2 |
|
|
2021 (July) | Ongoing |
| 3 | COVAXHIV - HIV-COV PLWH - 6 months post dose 2 |
|
|
2021 (October) | Ongoing |
| 4 | COVAXHIV - HIV-COV PLWH - 4 weeks post dose 3 |
|
|
2021 (November) | Ongoing |
| 5 | COVAXHIV - HIV-COV PLWH - 12 months post dose 2 |
|
|
2022 (April) | Ongoing |
| 6 | COVAXHIV - HIV-COV PLWH - 6 months post dose 3 |
|
|
2022 (April) | Ongoing |
| 7 | COVAXHIV - HIV-COV PLWH - 12 months post dose 3 |
|
|
2022 (October) | Ongoing |
COVAXHIV - HIV-COV Non-HIV
The population is composed of individuals of 18 years of age and older, who are HIV-negative and participants in the Stop the Spread Ottawa research project that included people who may have tested positive for SARS-CoV-2 infection, been vaccinated, or both.
Selection Criteria
- Minimum age
-
18
- Countries
-
- Canada
- Canadian Provinces
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- Ontario
- 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.
- 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.
- 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.
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Participants from Existing Studies
-
- Stop the Spread Ottawa research project
Sample Size
- Number of Participants
- 1,032
- Number of Participants with Biological Samples
- 986
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - HIV-COV Non-HIV - Baseline |
|
|
2020 (October) | 2022 (February) |
| 1 | COVAXHIV - HIV-COV Non-HIV - Follow-up 1 |
|
|
2020 (November) | 2020 (November) |
| 2 | COVAXHIV - HIV-COV Non-HIV - Follow-up 2 |
|
|
2020 (December) | 2020 (December) |
| 3 | COVAXHIV - HIV-COV Non-HIV - Follow-up 3 |
|
|
2021 (January) | 2021 (January) |
| 4 | COVAXHIV - HIV-COV Non-HIV - Follow-up 4 |
|
|
2021 (February) | 2021 (February) |
| 5 | COVAXHIV - HIV-COV Non-HIV - Follow-up 5 |
|
|
2021 (March) | 2021 (March) |
| 6 | COVAXHIV - HIV-COV Non-HIV - Follow-up 6 |
|
|
2021 (April) | 2021 (April) |
| 7 | COVAXHIV - HIV-COV Non-HIV - Follow-up 7 |
|
|
2021 (May) | 2021 (May) |
| 8 | COVAXHIV - HIV-COV Non-HIV - Follow-up 8 |
|
|
2021 (June) | 2021 (June) |
| 9 | COVAXHIV - HIV-COV Non-HIV - Follow-up 9 |
|
|
2021 (July) | 2021 (July) |
| 10 | COVAXHIV - HIV-COV Non-HIV - Follow-up 10 |
|
|
2021 (August) | 2021 (August) |
| 11 | COVAXHIV - HIV-COV Non-HIV - Follow-up 11 |
|
|
2021 (September) | 2021 (September) |
| 12 | COVAXHIV - HIV-COV Non-HIV - Follow-up 12 |
|
|
2021 (October) | 2021 (October) |
| 13 | COVAXHIV - HIV-COV Non-HIV - Follow-up 13 |
|
|
2021 (November) | 2021 (November) |
| 14 | COVAXHIV - HIV-COV Non-HIV - Follow-up 14 |
|
|
2021 (December) | 2021 (December) |
| 15 | COVAXHIV - HIV-COV Non-HIV - Follow-up 15 |
|
|
2022 (January) | 2022 (January) |
| 16 | COVAXHIV - HIV-COV Non-HIV - Follow-up 16 |
|
|
2022 (February) | 2022 (February) |
| 17 | COVAXHIV - HIV-COV Non-HIV - Follow-up 17 |
|
|
2022 (March) | Ongoing |
COVAXHIV - Derived PLWH
The population is composed of individuals 19 years of age and older, living with HIV (PLWH) and residents of Ontario or British Columbia, who are participating in the Ontario HIV Treatment Network (OHTN) Cohort Study.
Selection Criteria
- Minimum age
-
16
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Ontario
- 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).
Sources of Recruitment
- Participants from Existing Studies
-
- ON HIV Treatment Network Cohort Study
- 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.
Sample Size
- Number of Participants
- 30,143
- Supplementary information about number of participants
-
ON Cohort: 21,037 participants
BC Cohort:9,106 participants (6686 vaccinated and 2220 unvaccinated, 496 tested-positive with COVID-19)
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - Derived PLWH - VE analyses |
|
2022 (March) | Ongoing |
COVAXHIV - Derived Non-HIV
The population is composed of individuals 19 years of age and older, who are not living with HIV and are residents in Ontario.
Selection Criteria
- Minimum age
-
19
- Countries
-
- Canada
- Canadian Provinces
-
- Ontario
- 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.
Sources of Recruitment
- General Population
-
- Selected sample
- Supplementary Information
-
Participants are identified from provincial administrative records.
Sample Size
- Number of Participants
- 29,495
- Supplementary information about number of participants
-
Cohort: 21,037 participants
TND: 8,458 participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - Derived Non-HIV - VE analyses |
|
2022 (March) | Ongoing |
COVAXHIV - TND PLWH Cases
The population is composed of individuals 19 years of age and older, living with HIV (PLWH) and residents of Ontario or British Columbia, tested positive for SARS-CoV-2 between December 14, 2020 to December 31, 2021.
Selection Criteria
- Minimum age
-
19
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Ontario
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are identified from provincial administrative records.
Sample Size
- Number of Participants
- 1,164
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - TND PLWH Cases - VE analyses |
|
2022 (February) | Ongoing |
COVAXHIV - TND PLWH Controls
The population is composed of individuals 19 years of age and older, living with HIV (PLWH), residents of Ontario or British Columbia, tested negative for SARS-CoV-2 between December 14, 2020 to December 31, 2021.
Selection Criteria
- Minimum age
-
19
- Countries
-
- Canada
- Canadian Provinces
-
- British Columbia
- Ontario
- 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.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants are identified from provincial administrative records.
Sample Size
- Number of Participants
- 7,294
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | COVAXHIV - TND PLWH Controls - VE analyses |
|
2022 (February) | 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: 2024-04-01T10:07:26.400