Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff

SARS-CoV-2 Infection Clinical Trial

— DIA-Vacc  

Official title:

Investigation of the Immune Response Before and After COVID-19 Disease or SARS-CoV-2 Vaccination in Dialysis Patients, Solid Organ Recipients and Medical Staff

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799808
• Other study ID #: DIA-Vacc-21
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Technische Universität Dresden
• Contact: Christian Hugo, Prof.
• Phone: +49351458 4879
• Email: Christian.Hugo[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

- Formation of two separate cohorts of approximately 1000 study subjects each from the three categories (dialysis patients, solid organ transplant recipients and medical staff) of participants vaccinated using either Biontech or Moderna vaccine (Biontech cohort and Moderna cohort, approximately 2000 subjects total). - Study time points: Before administration of the 1st SARS-CoV-2 vaccine dose, before the 2nd vaccine dose, and 8 weeks and 6, 9, 12, and 18 months after administration of the 1st vaccine dose and after suspected or proven SARS-CoV-2 infection. - At all time points, a questionnaire or eCRF will be completed with questions about the dialysis center and the clinical course of the patients. - Humoral immune response will be determined in all study participants. - Formation of a study subgroup of up to 300 subjects in each cohort (Biontech or Moderna cohort) for detailed evaluation of the cellular immune response (max. 600 subjects in total). - In case of non-sustained immunity > 6 months as well as the occurrence of a 3rd SARS-CoV-2 infection wave in autumn 2021, this will be investigated analogously to the current wave.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Dialysis patients, organ transplant recipients and medical staff
• written consent to participate in the study

Exclusion Criteria:

• Age < 18 years old

Related Conditions & MeSH terms

• Active Immunization
• COVID-19
• Immune Response
• Immunosuppression
• Infections
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
Germany	Univercity Hospital Carl Gustav Carus	Dresden	Saxony

Sponsors (6)

Lead Sponsor	Collaborator
Technische Universität Dresden	Charite University, Berlin, Germany, DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden, DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen, Klinikum St. Georg gGmbH, Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Immune response to SARS-CoV-2 infection or vaccination	Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection	15 months after vaccination or infection
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	3 to 4 weeks after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	8 weeks after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	4 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	6 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	9 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	12 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	15 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	18 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	21 months after infection or vaccination
Primary	Cellular response to SARS-CoV-2 infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC).	24 months after infection or vaccination
Secondary	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
Secondary	SARS-CoV-2 incidence and prevalence	Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period	8 weeks after infection or vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	3 to 4 weeks after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	8 weeks after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	4 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	6 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	9 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	12 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	15 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	18 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	21 months after infection or vaccination
Secondary	Strength of immune response	Assessment of the quantity and specificity of the immune response	24 months after infection or vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	3 to 4 weeks after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	8 weeks after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	4 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	6 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	9 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	12 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	15 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	18 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	21 months after vaccination
Secondary	SARS-CoV-2 vaccination side effects	Assessing side effects of the different vaccinations in the study cohorts	24 months after vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	3 to 4 weeks after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	8 weeks after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	4 months after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	6 months after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	9 months after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	12 after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	15 after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	18 months after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	21 months after vaccination
Secondary	Duration of vaccination effect	Assessment of the duration of an achieved vaccination protection (clinical/immunological)	24 months after vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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