Active Immunization, Immune Response, Immunosuppression, SARS-CoV-2 Infection
Conditions
Keywords
SARS-CoV-2, Covid-19, dialysis, immunosuppression, solid organ transplantation, kidney transplant recipients, humoral immimmune response, cellular immune response
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.
Interventions
None listed
Sponsors
Universitätsklinikum Leipzig
Klinikum St. Georg gGmbH
Charite University, Berlin, Germany
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden
DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen
Technische Universität Dresden
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Dialysis patients, organ transplant recipients and medical staff * written consent to participate in the study
Exclusion criteria
* Age \< 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response to SARS-CoV-2 infection or vaccination | 3 to 4 weeks 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 | 3 to 4 weeks after vaccination or infection | SARS-CoV-2 IgA, IgM and different IgG antibody levels |
| Cellular response to SARS-CoV-2 infection or vaccination | 3 to 4 weeks after infection or vaccination | T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease | 3 to 4 weeks after vaccination | Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection |
| SARS-CoV-2 vaccination side effects | 3 to 4 weeks after vaccination | Assessing side effects of the different vaccinations in the study cohorts |
| Effectiveness of vaccination on severity and incidence of COVID-19 | 3 to 4 weeks after vaccination or infection | Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) |
| SARS-CoV-2 incidence and prevalence | 3 to 4 weeks after infection or vaccination | Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period |
| Compare vaccination effect in different vaccinations and risk populations | 3 to 4 weeks 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 | 3 to 4 weeks 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) |
| Duration of vaccination effect | 3 to 4 weeks after vaccination | Assessment of the duration of an achieved vaccination protection (clinical/immunological) |
| SARS-CoV-2 infection or immune response to vaccination | 3 to 4 weeks after infection or vaccination | Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination |
| Strength of immune response | 3 to 4 weeks after infection or vaccination | Assessment of the quantity and specificity of the immune response |
Countries
Germany
Contacts
Primary ContactChristian Hugo, Prof.
Backup ContactJulian Stumpf, Dr.
Outcome results
None listed