To investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immuneprotection or response at the humoral and cellular levels before and after SARS-CoV-2infection or vaccination in patients with moderately reduced immune status (dialysispatients) and severely reduced immune status (organ transplant recipients, mostly kidneytransplant recipients) and immunocompetent subjects (medical staff) in Saxony, Germany.
- 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.
Inclusion Criteria:
- Dialysis patients, organ transplant recipients and medical staff
- written consent to participate in the study
Exclusion Criteria:
- Age < 18 years old
Univercity Hospital Carl Gustav Carus
Dresden, Saxony, Germany
Investigator: Christian Hugo, Prof.
Contact: +49351458 4879
Christian.Hugo@uniklinikum-dresden.de
Christian Hugo, Prof.
+49351458 4879
Christian.Hugo@uniklinikum-dresden.de
Julian Stumpf, Dr.
+49351458 12165
Julian.Stumpf@uniklinikum-dresden.de
Christian Hugo, Prof., Study Director
Univercity Hospital Carl Gustav Carus