Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff
NCT ID: NCT04799808
Last Updated: 2022-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3500 participants
OBSERVATIONAL
2021-01-15
2023-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* written consent to participate in the study
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
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Universitätsklinikum Leipzig
OTHER
Klinikum St. Georg gGmbH
OTHER
Charite University, Berlin, Germany
OTHER
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden
UNKNOWN
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen
UNKNOWN
Technische Universität Dresden
OTHER
Responsible Party
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Susanne Dollfus
Prof. Dr. med. Christian Hugo
Principal Investigators
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Christian Hugo, Prof.
Role: STUDY_DIRECTOR
Univercity Hospital Carl Gustav Carus
Locations
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Univercity Hospital Carl Gustav Carus
Dresden, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DIA-Vacc-21
Identifier Type: -
Identifier Source: org_study_id
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