Vaccines in a Time of Dual Pandemic: COVID-19 Vaccine in People with HIV
Networks
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Datasets
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Variables
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The objective of this study is to understand the effect of COVID-19 vaccines on generating a SARS-CoV-2 specific immune response, inducing systemic immune activation and affecting HIV viral reservoirs in people with HIV (PWH).
- Start Year
- 2021
| Investigators | Contacts |
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Design
- Study design
- Cohort
- Follow Up
- Participants are followed over 48 weeks. Participants are followed 90 days after the screening visit at baseline. They are also followed 24 hours before dose 1 (visit 1), 10 days (Visit 2), 21 days (Visit 3), 28 days (Visit 4), 24 weeks (Visit 8), and 48 weeks (Visit 9) post-dose 1. The following visits are 1 to 3 days before dose 2 (Visit 4a), 7 days (Visit 6), 14 days (Visit 6), and 28 days(Visit 7) post-dose 2. The final visits are 1 to 3 days before dose 3 (Visit 8a), 4 weeks (Visit 8b), and 16 weeks (Visit 8c) post-dose 3.
- Supplementary Information
Recruitment
- Recruitment Target
-
- Individuals
Number of Participants
- Number of Participants
- 90
- Number of Participants with Biological Samples
- 90
- Supplementary Information
- PWH Immune responder: 42 participants PWH Immune non-responders: 20 participants PWH Low-level viremics: 5 participants HIV-negative control: 23 participants
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Timeline
Populations
The population is composed of HIV positive individuals with undetectable viral load for 1+ year, CD4 cell count greater than 500/uL, CD4/CD8 ratio greater than 1 and individuals with historical low CD4 nadir.
Selection Criteria
- Minimum age
-
55
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Inclusion criteria: * Documented HIV diagnosis for 1+ year. Exlusion criteria: * Participant with a malignancy or undergoing chemotherapy. * Active infection with hepatitis virus (HAV, HBV, HCV) or tuberculosis. * Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis; topical or ophthalmic corticosteroids for acute, uncomplicated dermatitis or conjunctivitis; over the counter medications for acute, uncomplicated dermatitis for treatment period not longer than 14 days) or other immunomodulator medications (other than NSAIDS which will be allowed for any length of time). * Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints. * Any other conditions judged by the investigator that would limit the evaluation of a participant. Positivity for sexually transmitted infections at the screening visit.
- Other Criteria
- Inclusion criteria: * Antiretroviral therapy for 1+ year Exclusion criteria: * Participants with a history of anaphylaxis reaction to the COVID-19 vaccine components. * Participants with any of the following abnormal laboratory results at the screening visit: Hemoglobin < 85 g/L; Lymphocyte count < .750 X109/L; Platelet count < 50 X109/L or > 550 X109/L; AST or ALT > 5X the upper limit of normal; Creatinine > 250 µmol/L; * Prior surgery or radiation therapy within 30 days of study screening or receipt of any other experimental compound within 30 days of signing informed consent. * Receipt of any blood product within 3 months prior to screening. * Receipt of any vaccine within 1 month prior to screening. * Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. * Use of any unproven registered and unregistered treatments for COVID-19; Administration of immunoglobulins and/ or any blood products within the three months preceding the planned administration of the vaccine candidate. * Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed).
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
Number of Participants
- Number of Participants
- 42
- Number of Participants with Biological Samples
- 42
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PWH-COVID19 - Immune responders - Screening
|
Information on the demographic, such as race/ethnicity and sex/gender, is collected. Concomitant medication history and cART regimen are documented. Routine blood work, in addition to viral ... | 2021-01 | 2021-01 |
| 1 |
PWH-COVID19 - Immune responders - Baseline
|
Concomitant medication history and cART regimen are documented. Saliva and routine blood work in addition to viral load, CD4 count, CD4/CD8 ratio are also collected. | 2021-03 | 2021-03 |
| 2 |
PWH-COVID19 - Immune responders - Visit 2
|
Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample if the participant was hospitalized) ... | 2021-03 | 2021-04 |
| 3 |
PWH-COVID19 - Immune responders - Visit 3
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-03 | 2021-04 |
| 4 |
PWH-COVID19 - Immune responders - Visit 4
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-04 | 2021-05 |
| 5 |
PWH-COVID19 - Immune responders - Additional visit 4a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-06 |
| 6 |
PWH-COVID19 - Immune responders - Visit 5
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-05 |
| 7 |
PWH-COVID19 - Immune responders - Visit 6
|
Information on new or continuing concomitant medications, including combination antiretroviral therapy (cART) regimen is assessed. Further information on COVID-19 infection is assessed. Blood ... | 2021-05 | 2021-05 |
| 9 |
PWH-COVID19 - Immune responders - Visit 7
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-06 | 2021-07 |
| 10 |
PWH-COVID19 - Immune responders - Visit 8
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 11 |
PWH-COVID19 - Immune responders - Additional visit 8a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 12 |
PWH-COVID19 - Immune responders - Additional visit 8b
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-11 | 2021-12 |
| 13 |
PWH-COVID19 - Immune responders - Additional visit 8c
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
| 14 |
PWH-COVID19 - Immune responders - Visit 9
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
The population is composed of HIV positive individuals with undetectable viral load for 1+ year, CD4 cell count less than 350/uL, CD4/CD8 ratio less than 0.75 for 1+ year.
Selection Criteria
- Minimum age
-
55
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Inclusion criteria: * Documented HIV diagnosis for 1+ year. Exlusion criteria: * Participant with a malignancy or undergoing chemotherapy. * Active infection with hepatitis virus (HAV, HBV, HCV) or tuberculosis. * Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis; topical or ophthalmic corticosteroids for acute, uncomplicated dermatitis or conjunctivitis; over the counter medications for acute, uncomplicated dermatitis for treatment period not longer than 14 days) or other immunomodulator medications (other than NSAIDS which will be allowed for any length of time). * Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints. * Any other conditions judged by the investigator that would limit the evaluation of a participant. * Positivity for sexually transmitted infections at the screening visit.
- Other Criteria
- Inclusion criteria: * Antiretroviral therapy for 1+ year. Exclusion criteria: * Participants with a history of anaphylaxis reaction to the COVID-19 vaccine components. * Participants with any of the following abnormal laboratory results at the screening visit: Hemoglobin < 85 g/L; Lymphocyte count < .750 X109/L; Platelet count < 50 X109/L or > 550 X109/L; AST or ALT > 5X the upper limit of normal; Creatinine > 250 µmol/L Prior surgery or radiation therapy within 30 days of study screening or receipt of any other experimental compound within 30 days of signing informed consent. * Receipt of any blood product within 3 months prior to screening. * Receipt of any vaccine within 1 month prior to screening. * Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. * Use of any unproven registered and unregistered treatments for COVID-19 * Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. * Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed).
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
- Supplementary Information
-
With the progression of the enrolment, the study will recruit more people in the PWH Immune non-responders arms with appropriate procedures and feasibility
Number of Participants
- Number of Participants
- 20
- Number of Participants with Biological Samples
- 20
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PWH-COVID19 - Immune non-responders - Screening
|
Information on the demographic such as race/ethnicity and sex/gender is collected. Concomitant medication history and cART regimen are documented. Routine blood work in addition to viral load, ... | 2021-01 | 2021-01 |
| 1 |
PWH-COVID19 - Immune non-responders - Baseline
|
Information on the demographic such as race/ethnicity and sex/gender is collected. Concomitant medication history and cART regimen are documented. Routine blood work in addition to viral load, ... | 2021-03 | 2021-03 |
| 2 |
PWH-COVID19 - Immune non-responders - Visit 2
|
Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample if the participant was hospitalized) ... | 2021-03 | 2021-04 |
| 3 |
PWH-COVID19 - Immune non-responders - Visit 3
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-03 | 2021-04 |
| 4 |
PWH-COVID19 - Immune non-responders - Visit 4
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-04 | 2021-05 |
| 5 |
PWH-COVID19 - Immune non-responders - Additional visit 4a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-06 |
| 6 |
PWH-COVID19 - Immune non-responders - Visit 5
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-05 |
| 7 |
PWH-COVID19 - Immune non-responders - Visit 6
|
Information on new or continuing concomitant medications, including combination antiretroviral therapy (cART) regimen is assessed. Further information on COVID-19 infection is assessed. Blood ... | 2021-05 | 2021-05 |
| 9 |
PWH-COVID19 - Immune non-responders - Visit 7
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-06 | 2021-07 |
| 10 |
PWH-COVID19 - Immune non-responders - Visit 8
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 11 |
PWH-COVID19 - Immune non-responders - Additional visit 8a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 12 |
PWH-COVID19 - Immune non-responders - Additional visit 8b
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-11 | 2021-12 |
| 13 |
PWH-COVID19 - Immune non-responders - Additional visit 8c
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
| 14 |
PWH-COVID19 - Immune non-responders - Visit 9
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
The population is composed of HIV positive individuals with low viremics defined as less than 1,000 copies/mL for 1 + year, any CD4 cell counts, and any CD4/CD8 ratio.
Selection Criteria
- Minimum age
-
55
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Inclusion criteria: * Documented HIV diagnosis for 1+ year. Exlusion criteria: * Participant with a malignancy or undergoing chemotherapy. * Active infection with hepatitis virus (HAV, HBV, HCV) or tuberculosis. * Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis; topical or ophthalmic corticosteroids for acute, uncomplicated dermatitis or conjunctivitis; over the counter medications for acute, uncomplicated dermatitis for treatment period not longer than 14 days) or other immunomodulator medications (other than NSAIDS which will be allowed for any length of time). * Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints. * Any other conditions judged by the investigator that would limit the evaluation of a participant. * Positivity for sexually transmitted infections at the screening visit.
- Other Criteria
- Inclusion criteria: * Antiretroviral therapy for 1+ year. Exclusion criteria: * Participants with a history of anaphylaxis reaction to the COVID-19 vaccine components. * Participants with any of the following abnormal laboratory results at the screening visit: Hemoglobin < 85 g/L; Lymphocyte count < .750 X109/L; Platelet count < 50 X109/L or > 550 X109/L; AST or ALT > 5X the upper limit of normal; Creatinine > 250 µmol/L * Prior surgery or radiation therapy within 30 days of study screening or receipt of any other experimental compound within 30 days of signing informed consent. * Receipt of any blood product within 3 months prior to screening. * Receipt of any vaccine within 1 month prior to screening. * Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. * Use of any unproven registered and unregistered treatments for COVID-19; Administration of immunoglobulins and/ or any blood products within the three months preceding the planned administration of the vaccine candidate. * Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed).
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
- Supplementary Information
-
With the progression of the enrolment, the study will recruit more people in the PWH Low-level viremics group with appropriate procedures and feasibility
Number of Participants
- Number of Participants
- 5
- Number of Participants with Biological Samples
- 5
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PWH-COVID19 - Low-level viremics - Screening
|
Information on the demographic such as race/ethnicity and sex/gender is collected. Concomitant medication history and cART regimen are documented. Routine blood work in addition to viral load, ... | 2021-01 | 2021-01 |
| 1 |
PWH-COVID19 - Low-level viremics - Baseline
|
Concomitant medication history and cART regimen are documented. Saliva and routine blood work in addition to viral load, CD4 count, CD4/CD8 ratio are also collected. | 2021-03 | 2021-03 |
| 2 |
PWH-COVID19 - Low-level viremics - Visit 2
|
Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample if the participant was hospitalized) ... | 2021-03 | 2021-04 |
| 3 |
PWH-COVID19 - Low-level viremics - Visit 3
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-03 | 2021-04 |
| 4 |
PWH-COVID19 - Low-level viremics - Visit 4
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-04 | 2021-05 |
| 5 |
PWH-COVID19 - Low-level viremics - Additional visit 4a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-06 |
| 6 |
PWH-COVID19 - Low-level viremics - Visit 5
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-05 |
| 7 |
PWH-COVID19 - Low-level viremics - Visit 6
|
Information on new or continuing concomitant medications, including combination antiretroviral therapy (cART) regimen is assessed. Further information on COVID-19 infection is assessed. Blood ... | 2021-05 | 2021-05 |
| 9 |
PWH-COVID19 - Low-level viremics - Visit 7
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-06 | 2021-07 |
| 10 |
PWH-COVID19 - Low-level viremics - Visit 8
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 11 |
PWH-COVID19 - Low-level viremics - Additional visit 8a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 12 |
PWH-COVID19 - Low-level viremics - Additional visit 8b
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-11 | 2021-12 |
| 13 |
PWH-COVID19 - Low-level viremics - Additional visit 8c
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
| 14 |
PWH-COVID19 - Low-level viremics - Visit 9
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
The population is composed of HIV negative individuals matched for age and sex with PWH individuals.
Selection Criteria
- Minimum age
-
55
- Newborns
- Twins
- Countries
-
- Canada
- Territory
- Ethnic Origin
-
- Health Status
-
- Inclusion criteria: * Negative HIV test at the screening visit. * Stable clinical status and absence of acute illnesses as shown by medical history and screening laboratory tests at the screening visit: Hemoglobin ≥ 85 g/L White blood cell (WBC) count = 3300 to 12,000 cells/mm3; Total lymphocyte count ≥ 800 cells/mm3; Platelets = 50,000 to 550,000/mm3; Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase < 5 times the institutional upper limit of normal (ULN); creatinine (Cr) ≤ institutional upper limit of normal; creatine phosphokinase (CPK) ≤ 2 times the institutional upper limit of normal not related to physical exertion.
- Other Criteria
- Exclusion criteria: * Participant with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death. * Further, pariticipants with immune-compromising conditions or on medication which suppresses the immune response will not be included in the study.
Recruitment
- Sources of recruitment
-
- General population
- General Population
-
- Volunteer enrolment
Number of Participants
- Number of Participants
- 23
- Number of Participants with Biological Samples
- 23
Data Collection Events
| # | Name | Description | Start | End |
|---|---|---|---|---|
| 0 |
PWH-COVID19 - Control - Screening
|
Information on the demographic such as race/ethnicity and sex/gender is collected. Concomitant medication history and cART regimen are documented. Routine blood work and an HIV test are performed. | 2021-01 | 2021-01 |
| 1 |
PWH-COVID19 - Control - Baseline
|
Saliva and blood samples are collected. | 2021-03 | 2021-03 |
| 2 |
PWH-COVID19 - Control - Visit 2
|
Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample if the participant was hospitalized) ... | 2021-03 | 2021-04 |
| 3 |
PWH-COVID19 - Control - Visit 3
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-03 | 2021-04 |
| 4 |
PWH-COVID19 - Control - Visit 4
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-04 | 2021-05 |
| 5 |
PWH-COVID19 - Control - Additional visit 4a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-06 |
| 6 |
PWH-COVID19 - Control - Visit 5
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-05 | 2021-05 |
| 7 |
PWH-COVID19 - Control - Visit 6
|
Information on new or continuing concomitant medications, including combination antiretroviral therapy (cART) regimen is assessed. Further information on COVID-19 infection is assessed. A blood ... | 2021-05 | 2021-05 |
| 9 |
PWH-COVID19 - Control - Visit 7
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-06 | 2021-07 |
| 10 |
PWH-COVID19 - Control - Visit 8
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 11 |
PWH-COVID19 - Control - Additional visit 8a
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-09 | 2021-11 |
| 12 |
PWH-COVID19 - Control - Additional visit 8b
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-11 | 2021-12 |
| 13 |
PWH-COVID19 - Control - Additional visit 8c
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
| 14 |
PWH-COVID19 - Control - Visit 9
|
Information about vaccination (vaccination card) is collected. Documentation of COVID-19 infection is assessed by specific symptoms and at least one nasopharyngeal swab, nasal swab, or saliva ... | 2021-12 | 2022-02 |
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
Diseases
Certain infectious and parasitic diseases (A00-B99)
Medication and supplements
Medication and supplement intake
Laboratory measures
Virology
Immunology
Administrative information