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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Response; SARS-CoV-2 Infection; Immunosuppression; Active Immunization

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Christian Hugo, Prof.; Phone Number: +49351458 4879; Email: Christian.Hugo@uniklinikum-dresden.de
• Study Contact Backup: Name: Julian Stumpf, Dr.; Phone Number: +49351458 12165; Email: Julian.Stumpf@uniklinikum-dresden.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Univercity Hospital Carl Gustav Carus
      • Contact: Christian Hugo, Prof.; Phone Number: +49351458 4879; Email: Christian.Hugo@uniklinikum-dresden.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

2000-3000 subjects

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Charite University, Berlin, Germany; Klinikum St. Georg gGmbH; Universitätsklinikum Leipzig; DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden; DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen
• Investigators: Study Director: Christian Hugo, Prof., Univercity Hospital Carl Gustav Carus

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; immunosuppression; Covid-19; dialysis; solid organ transplantation; kidney transplant recipients; humoral immimmune response; cellular immune response
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: DIA-Vacc-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No