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

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ClinicalTrials.gov Identifier: NCT04799808
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Susanne Dollfus, 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.

Condition or disease
SARS-CoV-2 Infection Active Immunization Immune Response Immunosuppression

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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort
BioNTech cohort
The BioNTech cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by comirnaty vaccine from BioNTech. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised solid organ transplant recipients, and the staff caring for them in the nephrology dispensaries.
Moderna cohort
The Moderna cohort is composed of 1000 study participants who will be protected from SARS-CoV-2 infection by Moderna Biotech vaccine. The study participants consist of mildly immunocompromised dialysis patients, severely immunocompromised kidney transplant recipients, and the staff caring for them in the nephrology dispensaries.



Primary Outcome Measures :
  1. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 3 to 4 weeks after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  2. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 8 weeks after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  3. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 6 months after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  4. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 9 months after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  5. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 12 months after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  6. Immune response to SARS-CoV-2 infection or vaccination [ Time Frame: 18 months after vaccination or infection ]
    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

  7. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 3 to 4 weeks after vaccination or infection ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  8. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 8 weeks after infection or vaccination ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  9. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 6 months after infection or vaccination ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  10. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 9 months after infection or vaccination ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  11. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 12 months after infection or vaccination ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  12. Humoral response to SARS-CoV-2 infection or vaccination [ Time Frame: 18 months after infection or vaccination ]
    SARS-CoV-2 IgA, IgM and different IgG antibody levels

  13. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 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).

  14. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 8 weeks after infection or vaccination ]
    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

  15. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 6 months after infection or vaccination ]
    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

  16. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 9 months after infection or vaccination ]
    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

  17. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 12 months after infection or vaccination ]
    T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) and flow cytometry (FC).

  18. Cellular response to SARS-CoV-2 infection or vaccination [ Time Frame: 18 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 :
  1. SARS-CoV-2 incidence and prevalence [ Time Frame: 3 to 4 weeks after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  2. SARS-CoV-2 incidence and prevalence [ Time Frame: 8 weeks after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  3. SARS-CoV-2 incidence and prevalence [ Time Frame: 6 months after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  4. SARS-CoV-2 incidence and prevalence [ Time Frame: 9 months after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  5. SARS-CoV-2 incidence and prevalence [ Time Frame: 12 months after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  6. SARS-CoV-2 incidence and prevalence [ Time Frame: 18 months after infection or vaccination ]
    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

  7. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 3 to 4 weeks after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  8. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 8 weeks after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  9. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 6 months after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  10. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 9 months after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  11. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 12 months after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  12. SARS-CoV-2 infection or immune response to vaccination [ Time Frame: 18 months after infection or vaccination ]
    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

  13. Strength of immune response [ Time Frame: 3 to 4 weeks after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  14. Strength of immune response [ Time Frame: 8 weeks after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  15. Strength of immune response [ Time Frame: 6 months after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  16. Strength of immune response [ Time Frame: 9 months after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  17. Strength of immune response [ Time Frame: 12 months after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  18. Strength of immune response [ Time Frame: 18 months after infection or vaccination ]
    Assessment of the quantity and specificity of the immune response

  19. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 3 to 4 weeks after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  20. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 8 weeks after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  21. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 6 months after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  22. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 9 months after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  23. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 12 months after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  24. Effect of SARS-CoV-2 vaccination on immune response after asymptomatic disease [ Time Frame: 18 months after vaccination ]
    Influence of vaccination on immunity/immune response in patients with asymptomatic SARS-CoV-2 infection

  25. SARS-CoV-2 vaccination side effects [ Time Frame: 3 to 4 weeks after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  26. SARS-CoV-2 vaccination side effects [ Time Frame: 8 weeks after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  27. SARS-CoV-2 vaccination side effects [ Time Frame: 6 months after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  28. SARS-CoV-2 vaccination side effects [ Time Frame: 9 months after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  29. SARS-CoV-2 vaccination side effects [ Time Frame: 12 months after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  30. SARS-CoV-2 vaccination side effects [ Time Frame: 18 months after vaccination ]
    Assessing side effects of the different vaccinations in the study cohorts

  31. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 3 to 4 weeks after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  32. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 8 weeks after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  33. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 6 months after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  34. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 9 months after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  35. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 12 months after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  36. Effectiveness of vaccination on severity and incidence of COVID-19 [ Time Frame: 18 months after vaccination or infection ]
    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

  37. Duration of vaccination effect [ Time Frame: 3 to 4 weeks after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  38. Duration of vaccination effect [ Time Frame: 8 weeks after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  39. Duration of vaccination effect [ Time Frame: 6 months after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  40. Duration of vaccination effect [ Time Frame: 9 months after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  41. Duration of vaccination effect [ Time Frame: 12 after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  42. Duration of vaccination effect [ Time Frame: 18 months after vaccination ]
    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

  43. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 3 to 4 weeks after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  44. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 8 weeks after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  45. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 6 months after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  46. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 9 months after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  47. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 12 months after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  48. Compare vaccination effect in different vaccinations and risk populations [ Time Frame: 18 months after vaccination ]
    Comparison of vaccination effects/protection in a randomized study cohort with BioNTech vaccine and one with Moderna vaccine

  49. Protection of re-boostering if necessary [ Time Frame: 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)

  50. Protection of re-boostering if necessary [ Time Frame: 8 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)

  51. Protection of re-boostering if necessary [ Time Frame: 6 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)

  52. Protection of re-boostering if necessary [ Time Frame: 9 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)

  53. Protection of re-boostering if necessary [ Time Frame: 12 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)

  54. Protection of re-boostering if necessary [ Time Frame: 18 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)


Biospecimen Retention:   Samples Without DNA
Blood samples, in particular serum and PBMCs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
2000-3000 subjects
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799808


Contacts
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Contact: Christian Hugo, Prof. +49351458 4879 Christian.Hugo@uniklinikum-dresden.de
Contact: Julian Stumpf, Dr. +49351458 12165 Julian.Stumpf@uniklinikum-dresden.de

Locations
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Germany
Univercity Hospital Carl Gustav Carus Recruiting
Dresden, Saxony, Germany, 01307
Contact: Christian Hugo, Prof.    +49351458 4879    Christian.Hugo@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
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
Investigators
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Study Director: Christian Hugo, Prof. Univercity Hospital Carl Gustav Carus
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Responsible Party: Susanne Dollfus, Prof. Dr. med. Christian Hugo, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT04799808    
Other Study ID Numbers: DIA-Vacc-21
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanne Dollfus, Technische Universität Dresden:
SARS-CoV-2
Covid-19
dialysis
immunosuppression
solid organ transplantation
kidney transplant recipients
humoral immimmune response
cellular immune response
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases