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.
* 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 Type
OBSERVATIONAL
Enrollment
3,500
Univercity Hospital Carl Gustav Carus
Dresden, Saxony, Germany
RECRUITINGImmune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 3 to 4 weeks after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 8 weeks after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 4 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 6 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 9 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 12 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 15 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 18 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 21 months after vaccination or infection
Immune response to SARS-CoV-2 infection or vaccination
Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection
Time frame: 24 months after vaccination or infection
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 3 to 4 weeks after vaccination or infection
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 8 weeks after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 4 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 6 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 9 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 12 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 15 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 18 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 21 months after infection or vaccination
Humoral response to SARS-CoV-2 infection or vaccination
SARS-CoV-2 IgA, IgM and different IgG antibody levels
Time frame: 24 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 3 to 4 weeks after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 8 weeks after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 4 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 6 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 9 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 12 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 15 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 18 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 21 months after infection or vaccination
Cellular response to SARS-CoV-2 infection or vaccination
T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).
Time frame: 24 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 3 to 4 weeks after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 8 weeks after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 4 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 6 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 9 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 12 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 15 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 18 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 21 months after infection or vaccination
SARS-CoV-2 incidence and prevalence
Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period
Time frame: 24 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 3 to 4 weeks after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 8 weeks after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 4 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 6 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 9 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 12 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 15 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 18 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 21 months after infection or vaccination
SARS-CoV-2 infection or immune response to vaccination
Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination
Time frame: 24 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 3 to 4 weeks after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 8 weeks after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 4 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 6 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 9 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 12 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 15 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 18 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 21 months after infection or vaccination
Strength of immune response
Assessment of the quantity and specificity of the immune response
Time frame: 24 months after infection or vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 3 to 4 weeks after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 8 weeks after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 4 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 6 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 9 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 12 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 15 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 18 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 21 months after vaccination
Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease
Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection
Time frame: 24 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 3 to 4 weeks after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 8 weeks after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 4 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 6 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 9 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 12 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 15 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 18 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 21 months after vaccination
SARS-CoV-2 vaccination side effects
Assessing side effects of the different vaccinations in the study cohorts
Time frame: 24 months after vaccination
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 3 to 4 weeks after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 8 weeks after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 4 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 6 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 9 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 12 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 15 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 18 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 21 months after vaccination or infection
Effectiveness of vaccination on severity and incidence of COVID-19
Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)
Time frame: 24 months after vaccination or infection
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 3 to 4 weeks after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 8 weeks after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 4 months after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 6 months after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 9 months after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 12 after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 15 after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 18 months after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 21 months after vaccination
Duration of vaccination effect
Assessment of the duration of an achieved vaccination protection (clinical/immunological)
Time frame: 24 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 3 to 4 weeks after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 8 weeks after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 4 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 6 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 9 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 12 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 15 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 18 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 21 months after vaccination
Compare vaccination effect in different vaccinations and risk populations
Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine
Time frame: 24 months after vaccination
Protection of re-boostering if necessary
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)
Time frame: 3 to 4 weeks after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 8 weeks after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 4 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 6 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 9 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 12 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 15 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 18 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 21 months after re-boostering
Protection of re-boostering if necessary
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)
Time frame: 24 months after re-boostering