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AzTrials

SARS-CoV-2 InfectionDIA-VaccNCT04799808

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

An observational study of SARS-CoV-2 Infection and Active Immunization, run by Technische Universität Dresden at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Type of treatment
Vaccines
How many people
3,500 participants
Where
1 siteGermany
Study dates
15 Jan 2021to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 2000-3000 subjects

Who may be able to join

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

Who cannot join

  • Age < 18 years old

Trial locations and contacts

1 site in 1 country.

Christian Hugo, Prof. contact

+49351458 4879

Christian.Hugo@uniklinikum-dresden.de

Julian Stumpf, Dr. contact

+49351458 12165

Julian.Stumpf@uniklinikum-dresden.de

Germany1 site, 1 recruiting

  • Univercity Hospital Carl Gustav Carus

    Dresden, Saxony, 01307

    Christian Hugo, Prof., +49351458 4879, Christian.Hugo@uniklinikum-dresden.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the 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.
Keywords
SARS-CoV-2, Covid-19, dialysis, immunosuppression, solid organ transplantation, kidney transplant recipients, humoral immimmune response, cellular immune response
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04799808
Study groupRoleWhat they receive
BioNTech cohortThe 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 cohortThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 3 to 4 weeks after vaccination or infection

  2. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 8 weeks after vaccination or infection

  3. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 4 months after vaccination or infection

  4. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 6 months after vaccination or infection

  5. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 9 months after vaccination or infection

  6. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 12 months after vaccination or infection

  7. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 15 months after vaccination or infection

  8. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 18 months after vaccination or infection

  9. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 21 months after vaccination or infection

  10. Immune response to SARS-CoV-2 infection or vaccination

    Swab-PCR and/or serological and/or SARS-CoV-2 rapid test proven infection

    Measured: 24 months after vaccination or infection

  11. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 3 to 4 weeks after vaccination or infection

  12. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 8 weeks after infection or vaccination

  13. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 4 months after infection or vaccination

  14. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 6 months after infection or vaccination

  15. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 9 months after infection or vaccination

  16. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 12 months after infection or vaccination

  17. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 15 months after infection or vaccination

  18. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 18 months after infection or vaccination

  19. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 21 months after infection or vaccination

  20. Humoral response to SARS-CoV-2 infection or vaccination

    SARS-CoV-2 IgA, IgM and different IgG antibody levels

    Measured: 24 months after infection or vaccination

  21. 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).

    Measured: 3 to 4 weeks after infection or vaccination

  22. 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).

    Measured: 8 weeks after infection or vaccination

  23. 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).

    Measured: 4 months after infection or vaccination

  24. 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).

    Measured: 6 months after infection or vaccination

  25. 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).

    Measured: 9 months after infection or vaccination

  26. 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).

    Measured: 12 months after infection or vaccination

  27. 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).

    Measured: 15 months after infection or vaccination

  28. 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).

    Measured: 18 months after infection or vaccination

  29. 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).

    Measured: 21 months after infection or vaccination

  30. 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).

    Measured: 24 months after infection or vaccination

Secondary outcomes (90)

  1. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 3 to 4 weeks after infection or vaccination

  2. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 8 weeks after infection or vaccination

  3. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 4 months after infection or vaccination

  4. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 6 months after infection or vaccination

  5. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 9 months after infection or vaccination

  6. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 12 months after infection or vaccination

  7. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 15 months after infection or vaccination

  8. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 18 months after infection or vaccination

  9. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 21 months after infection or vaccination

  10. SARS-CoV-2 incidence and prevalence

    Survey of the incidence and prevalence of asymptomatic SARS-CoV-2 infections over the study period

    Measured: 24 months after infection or vaccination

  11. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 3 to 4 weeks after infection or vaccination

  12. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 8 weeks after infection or vaccination

  13. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 4 months after infection or vaccination

  14. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 6 months after infection or vaccination

  15. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 9 months after infection or vaccination

  16. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 12 months after infection or vaccination

  17. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 15 months after infection or vaccination

  18. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 18 months after infection or vaccination

  19. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 21 months after infection or vaccination

  20. SARS-CoV-2 infection or immune response to vaccination

    Differentiation of immunity with respect to SARS-CoV-2 infection versus SARS-CoV-2 vaccination

    Measured: 24 months after infection or vaccination

  21. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 3 to 4 weeks after infection or vaccination

  22. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 8 weeks after infection or vaccination

  23. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 4 months after infection or vaccination

  24. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 6 months after infection or vaccination

  25. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 9 months after infection or vaccination

  26. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 12 months after infection or vaccination

  27. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 15 months after infection or vaccination

  28. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 18 months after infection or vaccination

  29. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 21 months after infection or vaccination

  30. Strength of immune response

    Assessment of the quantity and specificity of the immune response

    Measured: 24 months after infection or vaccination

  31. 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

    Measured: 3 to 4 weeks after vaccination

  32. 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

    Measured: 8 weeks after vaccination

  33. 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

    Measured: 4 months after vaccination

  34. 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

    Measured: 6 months after vaccination

  35. 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

    Measured: 9 months after vaccination

  36. 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

    Measured: 12 months after vaccination

  37. 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

    Measured: 15 months after vaccination

  38. 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

    Measured: 18 months after vaccination

  39. 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

    Measured: 21 months after vaccination

  40. 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

    Measured: 24 months after vaccination

  41. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 3 to 4 weeks after vaccination

  42. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 8 weeks after vaccination

  43. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 4 months after vaccination

  44. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 6 months after vaccination

  45. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 9 months after vaccination

  46. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 12 months after vaccination

  47. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 15 months after vaccination

  48. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 18 months after vaccination

  49. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 21 months after vaccination

  50. SARS-CoV-2 vaccination side effects

    Assessing side effects of the different vaccinations in the study cohorts

    Measured: 24 months after vaccination

  51. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 3 to 4 weeks after vaccination or infection

  52. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 8 weeks after vaccination or infection

  53. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 4 months after vaccination or infection

  54. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 6 months after vaccination or infection

  55. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 9 months after vaccination or infection

  56. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 12 months after vaccination or infection

  57. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 15 months after vaccination or infection

  58. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 18 months after vaccination or infection

  59. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 21 months after vaccination or infection

  60. Effectiveness of vaccination on severity and incidence of COVID-19

    Assess clinical effectiveness of vaccination (incidence and severity of symptomatic COVID-19 disease)

    Measured: 24 months after vaccination or infection

  61. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 3 to 4 weeks after vaccination

  62. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 8 weeks after vaccination

  63. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 4 months after vaccination

  64. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 6 months after vaccination

  65. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 9 months after vaccination

  66. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 12 after vaccination

  67. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 15 after vaccination

  68. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 18 months after vaccination

  69. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 21 months after vaccination

  70. Duration of vaccination effect

    Assessment of the duration of an achieved vaccination protection (clinical/immunological)

    Measured: 24 months after vaccination

  71. 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

    Measured: 3 to 4 weeks after vaccination

  72. 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

    Measured: 8 weeks after vaccination

  73. 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

    Measured: 4 months after vaccination

  74. 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

    Measured: 6 months after vaccination

  75. 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

    Measured: 9 months after vaccination

  76. 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

    Measured: 12 months after vaccination

  77. 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

    Measured: 15 months after vaccination

  78. 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

    Measured: 18 months after vaccination

  79. 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

    Measured: 21 months after vaccination

  80. 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

    Measured: 24 months after vaccination

  81. 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)

    Measured: 3 to 4 weeks after re-boostering

  82. 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)

    Measured: 8 weeks after re-boostering

  83. 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)

    Measured: 4 months after re-boostering

  84. 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)

    Measured: 6 months after re-boostering

  85. 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)

    Measured: 9 months after re-boostering

  86. 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)

    Measured: 12 months after re-boostering

  87. 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)

    Measured: 15 months after re-boostering

  88. 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)

    Measured: 18 months after re-boostering

  89. 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)

    Measured: 21 months after re-boostering

  90. 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)

    Measured: 24 months after re-boostering

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start15 Jan 2021
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799808
Sponsor's protocol ID
DIA-Vacc-21
Acronym
DIA-Vacc
Status last verified
Aug 2022
First submitted
8 Mar 2021
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 Infection and Active Immunization, run by Technische Universität Dresden at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christian Hugo, Prof. (+49351458 4879, Christian.Hugo@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune response to SARS-CoV-2 infection or vaccination (time frame: 3 to 4 weeks after vaccination or infection). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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