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

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

• Registration Number: NCT04799808
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune response to SARS-CoV-2 infection or vaccination	24 months after vaccination or infection	Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Humoral response to SARS-CoV-2 infection or vaccination	24 months after infection or vaccination	SARS-CoV-2 IgA, IgM and different IgG antibody levels
Cellular response to SARS-CoV-2 infection or vaccination	24 months after infection or vaccination	T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

Secondary Outcome Measures

Name	Time	Method
Effectiveness of vaccination on severity and incidence of COVID-19	24 months after vaccination or infection	Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
SARS-CoV-2 infection or immune response to vaccination	24 months after infection or vaccination	Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease	24 months after vaccination	Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Compare vaccination effect in different vaccinations and risk populations	24 months after vaccination	Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Protection of re-boostering if necessary	24 months after re-boostering	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)
Strength of immune response	24 months after infection or vaccination	Assessment of the quantity and specificity of the immune response
SARS-CoV-2 vaccination side effects	24 months after vaccination	Assessing side effects of the different vaccinations in the study cohorts
Duration of vaccination effect	24 months after vaccination	Assessment of the duration of an achieved vaccination protection (clinical/immunological)
SARS-CoV-2 incidence and prevalence	24 months after infection or vaccination	Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

Trial Locations

Locations (1)

Univercity Hospital Carl Gustav Carus; 🇩🇪 Dresden, Saxony, Germany