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| Name | Class |
|---|---|
| Universitätsklinikum Leipzig | OTHER |
| Klinikum St. Georg gGmbH | OTHER |
| Charite University, Berlin, Germany | OTHER |
| DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden |
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To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after SARS-CoV-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioNTech cohort | The BioNTech cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by comirnaty vaccine from BioNTech. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised solid organ transplant recipients, and the staff caring for them in the nephrology dispensaries. | ||
| Moderna cohort | The Moderna cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by Moderna Biotech vaccine. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised kidney transplant recipients, and the staff caring for them in the nephrology dispensaries. |
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| Measure | Description | Time Frame |
|---|---|---|
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 3 to 4 weeks after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 8 weeks after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 4 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 6 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 9 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 12 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 3 to 4 weeks after infection or vaccination |
| SARS-CoV-2 incidence and prevalence |
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Inclusion Criteria:
Exclusion Criteria:
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2000-3000 subjects
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Hugo, Prof. | Contact | +49351458 4879 | Christian.Hugo@uniklinikum-dresden.de | |
| Julian Stumpf, Dr. | Contact | +49351458 12165 | Julian.Stumpf@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Hugo, Prof. | Univercity Hospital Carl Gustav Carus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univercity Hospital Carl Gustav Carus | Recruiting | Dresden | Saxony | 01307 | Germany |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| UNKNOWN |
| DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen | UNKNOWN |
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Blood samples, in particular serum and PBMCs
| 15 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 18 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 21 months after vaccination or infection |
| Immune response to SARS-CoV-2 infection or vaccination | Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection | 24 months after vaccination or infection |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 3 to 4 weeks after vaccination or infection |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 8 weeks after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 4 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 6 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 9 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 12 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 15 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 18 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 21 months after infection or vaccination |
| Humoral response to SARS-CoV-2 infection or vaccination | SARS-CoV-2 IgA, IgM and different IgG antibody levels | 24 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 3 to 4 weeks after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 8 weeks after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 4 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 6 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 9 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 12 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 15 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 18 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 21 months after infection or vaccination |
| Cellular response to SARS-CoV-2 infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). | 24 months after infection or vaccination |
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
| 8 weeks after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 4 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 6 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 9 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 12 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 15 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 18 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 21 months after infection or vaccination |
| SARS-CoV-2 incidence and prevalence | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period | 24 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 3 to 4 weeks after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 8 weeks after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 4 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 6 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 9 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 12 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 15 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 18 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 21 months after infection or vaccination |
| SARS-CoV-2 infection or immune response to vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination | 24 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 3 to 4 weeks after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 8 weeks after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 4 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 6 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 9 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 12 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 15 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 18 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 21 months after infection or vaccination |
| Strength of immune response | Assessment of the quantity and specificity of the immune response | 24 months after infection or vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 3 to 4 weeks after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 8 weeks after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 4 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 6 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 9 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 12 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 15 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 18 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 21 months after vaccination |
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection | 24 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 3 to 4 weeks after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 8 weeks after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 4 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 6 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 9 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 12 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 15 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 18 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 21 months after vaccination |
| SARS-CoV-2 vaccination side effects | Assessing side effects of the different vaccinations in the study cohorts | 24 months after vaccination |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 3 to 4 weeks after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 8 weeks after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 4 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 6 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 9 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 12 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 15 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 18 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 21 months after vaccination or infection |
| Effectiveness of vaccination on severity and incidence of COVID-19 | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) | 24 months after vaccination or infection |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 3 to 4 weeks after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 8 weeks after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 4 months after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 6 months after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 9 months after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 12 after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 15 after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 18 months after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 21 months after vaccination |
| Duration of vaccination effect | Assessment of the duration of an achieved vaccination protection (clinical/immunological) | 24 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 3 to 4 weeks after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 8 weeks after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 4 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 6 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 9 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 12 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 15 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 18 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 21 months after vaccination |
| Compare vaccination effect in different vaccinations and risk populations | Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine | 24 months after vaccination |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 3 to 4 weeks after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 8 weeks after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 4 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 6 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 9 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 12 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 15 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 18 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 21 months after re-boostering |
| Protection of re-boostering if necessary | Assessment of vaccination protection and immune response in case of need for renewed, possibly corrected booster/refresher vaccination in fall 2021 (in case of a 3rd wave and/or in patients with absent or non-sustained vaccination protection) | 24 months after re-boostering |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |