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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04799808
Other study ID # DIA-Vacc-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Technische Universität Dresden
Contact Christian Hugo, Prof.
Phone +49351458 4879
Email Christian.Hugo@uniklinikum-dresden.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3500
Est. completion date December 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Locations

Country Name City State
Germany Univercity Hospital Carl Gustav Carus Dresden Saxony

Sponsors (6)

Lead Sponsor Collaborator
Technische Universität Dresden Charite University, Berlin, Germany, DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Dresden, DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH / Institut Plauen, Klinikum St. Georg gGmbH, Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 3 to 4 weeks after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 8 weeks after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 4 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 6 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 9 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 12 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 15 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 18 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 21 months after vaccination or infection
Primary Immune response to SARS-CoV-2 infection or vaccination Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection 24 months after vaccination or infection
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 3 to 4 weeks after vaccination or infection
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 8 weeks after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 4 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 6 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 9 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 12 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 15 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 18 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 21 months after infection or vaccination
Primary Humoral response to SARS-CoV-2 infection or vaccination SARS-CoV-2 IgA, IgM and different IgG antibody levels 24 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 3 to 4 weeks after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 8 weeks after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 4 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 6 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 9 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 12 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 15 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 18 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 21 months after infection or vaccination
Primary Cellular response to SARS-CoV-2 infection or vaccination T cell subtype immunity measured by SARS-CoV-2 interferon-? release assays (IGRA) and flow cytometry (FC). 24 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 3 to 4 weeks after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 8 weeks after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 4 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 6 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 9 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 12 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 15 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 18 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 21 months after infection or vaccination
Secondary SARS-CoV-2 incidence and prevalence Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period 24 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 3 to 4 weeks after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 8 weeks after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 4 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 6 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 9 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 12 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 15 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 18 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 21 months after infection or vaccination
Secondary SARS-CoV-2 infection or immune response to vaccination Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination 24 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 3 to 4 weeks after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 8 weeks after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 4 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 6 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 9 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 12 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 15 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 18 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 21 months after infection or vaccination
Secondary Strength of immune response Assessment of the quantity and specificity of the immune response 24 months after infection or vaccination
Secondary 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 3 to 4 weeks after vaccination
Secondary 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 8 weeks after vaccination
Secondary 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 4 months after vaccination
Secondary 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 6 months after vaccination
Secondary 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 9 months after vaccination
Secondary 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 12 months after vaccination
Secondary 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 15 months after vaccination
Secondary 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 18 months after vaccination
Secondary 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 21 months after vaccination
Secondary 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 24 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 3 to 4 weeks after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 8 weeks after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 4 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 6 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 9 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 12 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 15 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 18 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 21 months after vaccination
Secondary SARS-CoV-2 vaccination side effects Assessing side effects of the different vaccinations in the study cohorts 24 months after vaccination
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 3 to 4 weeks after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 8 weeks after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 4 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 6 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 9 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 12 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 15 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 18 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 21 months after vaccination or infection
Secondary Effectiveness of vaccination on severity and incidence of COVID-19 Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease) 24 months after vaccination or infection
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 3 to 4 weeks after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 8 weeks after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 4 months after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 6 months after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 9 months after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 12 after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 15 after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 18 months after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 21 months after vaccination
Secondary Duration of vaccination effect Assessment of the duration of an achieved vaccination protection (clinical/immunological) 24 months after vaccination
Secondary 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 3 to 4 weeks after vaccination
Secondary 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 8 weeks after vaccination
Secondary 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 4 months after vaccination
Secondary 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 6 months after vaccination
Secondary 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 9 months after vaccination
Secondary 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 12 months after vaccination
Secondary 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 15 months after vaccination
Secondary 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 18 months after vaccination
Secondary 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 21 months after vaccination
Secondary 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 24 months after vaccination
Secondary 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) 3 to 4 weeks after re-boostering
Secondary 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) 8 weeks after re-boostering
Secondary 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) 4 months after re-boostering
Secondary 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) 6 months after re-boostering
Secondary 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) 9 months after re-boostering
Secondary 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) 12 months after re-boostering
Secondary 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) 15 months after re-boostering
Secondary 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) 18 months after re-boostering
Secondary 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) 21 months after re-boostering
Secondary 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) 24 months after re-boostering
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