Clinical trial NCT04799808: Saxon SARS-CoV-2 Infection and Vaccination Study in Dialysis Patients, Solid Organ Recipients and Staff
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Active Immunization
Immune Response
Immunosuppression
Keywords: SARS-CoV-2
Covid-19
dialysis
immunosuppression
solid organ transplantation
kidney transplant recipients
humoral immimmune response
cellular immune response
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: Klinikum St. Georg gGmbH
name: Charite University, Berlin, Germany
name: DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden
name: DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen
First posted: 2021-03-16
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2000-3000 subjects

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 3 to 4 weeks after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 8 weeks after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 4 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 6 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 9 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 12 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 15 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 18 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 21 months after vaccination or infection
measure: Immune response to SARS-CoV-2 infection or vaccination
timeFrame: 24 months after vaccination or infection
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 3 to 4 weeks after vaccination or infection
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 8 weeks after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 4 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 6 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 9 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 12 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 15 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 18 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 21 months after infection or vaccination
measure: Humoral response to SARS-CoV-2 infection or vaccination
timeFrame: 24 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 3 to 4 weeks after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 8 weeks after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 4 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 6 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 9 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 12 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 15 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 18 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 21 months after infection or vaccination
measure: Cellular response to SARS-CoV-2 infection or vaccination
timeFrame: 24 months after infection or vaccination
Secondary outcomes:
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 3 to 4 weeks after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 8 weeks after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 4 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 6 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 9 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 12 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 15 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 18 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 21 months after infection or vaccination
measure: SARS-CoV-2 incidence and prevalence
timeFrame: 24 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 3 to 4 weeks after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 8 weeks after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 4 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 6 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 9 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 12 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 15 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 18 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 21 months after infection or vaccination
measure: SARS-CoV-2 infection or immune response to vaccination
timeFrame: 24 months after infection or vaccination
measure: Strength of immune response
timeFrame: 3 to 4 weeks after infection or vaccination
measure: Strength of immune response
timeFrame: 8 weeks after infection or vaccination
measure: Strength of immune response
timeFrame: 4 months after infection or vaccination
measure: Strength of immune response
timeFrame: 6 months after infection or vaccination
measure: Strength of immune response
timeFrame: 9 months after infection or vaccination
measure: Strength of immune response
timeFrame: 12 months after infection or vaccination
measure: Strength of immune response
timeFrame: 15 months after infection or vaccination
measure: Strength of immune response
timeFrame: 18 months after infection or vaccination
measure: Strength of immune response
timeFrame: 21 months after infection or vaccination
measure: Strength of immune response
timeFrame: 24 months after infection or vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 3 to 4 weeks after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 8 weeks after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 4 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 6 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 9 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 12 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 15 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 18 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 21 months after vaccination
measure: Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
timeFrame: 24 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 3 to 4 weeks after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 8 weeks after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 4 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 6 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 9 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 12 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 15 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 18 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 21 months after vaccination
measure: SARS-CoV-2 vaccination side effects
timeFrame: 24 months after vaccination
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 3 to 4 weeks after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 8 weeks after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 4 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 6 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 9 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 12 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 15 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 18 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 21 months after vaccination or infection
measure: Effectiveness of vaccination on severity and incidence of COVID-19
timeFrame: 24 months after vaccination or infection
measure: Duration of vaccination effect
timeFrame: 3 to 4 weeks after vaccination
measure: Duration of vaccination effect
timeFrame: 8 weeks after vaccination
measure: Duration of vaccination effect
timeFrame: 4 months after vaccination
measure: Duration of vaccination effect
timeFrame: 6 months after vaccination
measure: Duration of vaccination effect
timeFrame: 9 months after vaccination
measure: Duration of vaccination effect
timeFrame: 12 after vaccination
measure: Duration of vaccination effect
timeFrame: 15 after vaccination
measure: Duration of vaccination effect
timeFrame: 18 months after vaccination
measure: Duration of vaccination effect
timeFrame: 21 months after vaccination
measure: Duration of vaccination effect
timeFrame: 24 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 3 to 4 weeks after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 8 weeks after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 4 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 6 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 9 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 12 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 15 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 18 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 21 months after vaccination
measure: Compare vaccination effect in different vaccinations and risk populations
timeFrame: 24 months after vaccination
measure: Protection of re-boostering if necessary
timeFrame: 3 to 4 weeks after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 8 weeks after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 4 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 6 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 9 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 12 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 15 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 18 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 21 months after re-boostering
measure: Protection of re-boostering if necessary
timeFrame: 24 months after re-boostering
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Univercity Hospital Carl Gustav Carus
state: Saxony
Study officials:
affiliation: Univercity Hospital Carl Gustav Carus
name: Christian Hugo, Prof.
role: STUDY_DIRECTOR
References: