Trial document
DRKS00024668
Trial Description
Title
Observational study to assess the SARS-CoV-2 specific immune response in kidney transplant recipients (COVID-19 related immune response)
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
Kidney transplant recipients are due to their medical need of immunosuppressive medication following transplantation as well as their often coexisting comorbidities, especially regarding the cardiovascular system, at high risk for a severe course of COVID-19 disease when compared to healthy individuals. On the other hand the fast development of SARS-CoV_2 specific vaccines give hope to fighting the current COVID-19 pandemic.
It is already known, that the antibody-mediated as well as cell-mediated immune response of immunocompromised patients to other viral diseases or vaccinations against viral diseases, such as Influenza or Hepatitis B, is impaired. Current research suggests that immunocompromised patients develop an adequate immune response to an infection with SARS-CoV-2. It is however not known, how the immune response to SARS-CoV-2 specific vaccination is.
In this study the immune response following COVID-19 diesease or SARS-CoV-2 infection in renal transplant recipients will be assessed. Healthy participants without chronic kidney disease will serve as control.
Amendment 1: Patients with renal disease without kidney transplantation will be included as an additional study arm.
Brief Summary in Scientific Language
At present, two mRNA vaccines are approved for vaccination against COVID-19: BNT162b2/Comirnaty (BioNTech/Pfizer) and mRNA-1273/COVID-19-vaccine (Moderna). At the end of january another, vector-based vaccine, AZD1222 (AstraZeneca) further got approval. All three vaccines demonstrated sufficient efficacy in preventing COVID-19 disease and led to significant reduction in severe courses of COVID-19 disease in vaccinated participants. As the authorisation studies however only included healthy individuals, little is known about vaccine induced immunity in immunocompromised patients.
Studies regarding influenza vaccination in renal transplant recipients showed significant impaired vaccine-induced immunity due to immunosuppressive medication. In a prospective vaccination study regarding vaccination against Hepatitis A in immunisuppressed liver- and kidney transplant recipients a fast humoral response to vaccination could be demonstrated, however, antibody titers decreased faster than in healthy control participants.
Recent studies could show an adequate antibody-mediated and cellular response following SARS-CoV-2 infection, even in immunocompromised patients. However, little is known on how long this immunity after COVID-19 infection lasts.
In this observational trial the humoral and cellular response to SARS-CoV-2 antigen exposure, either by infection of by vaccination will be evaluated in renal transplant recipients. Participants without chronic kidney disease will serve as healthy controls.
Amendment 1: Patients with renal disease without kidney transplantation will be included as an additional study arm.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
Data will not be shared due to monocentric observational character of this study.
Organizational Data
- DRKS00024668
- 2021/03/23
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- yes
- Approved
- S-201/2021, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- 01KX2021 (BMBF Förderkennzeichen)
Health Condition or Problem studied
- Z94.0 - Kidney transplant status
- U07.1 - Emergency use of U07.1
Interventions/Observational Groups
- Investigation of SARS-CoV-2 specific immunity in Kidney transplant recipients or combined kidney-pancreas transplant recipients (de novo or re-transplanted)
- Investigation of SARS-CoV-2 specific immunity in Patients without chronic kidney disease (>CKD Stadium 3b (GFR >45 ml/min/1.73m2))
- Investigation of SARS-CoV-2 specific immunity in patients with renal disease without kidney transplantation
Characteristics
- Non-interventional
- Observational study
- Non-randomized controlled trial
- Open (masking not used)
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- Other
- Diagnostic
- Parallel
- IV
- N/A
Primary Outcome
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure
1) antibody-mediated immune response 28-42 days (=d) after SARS-CoV-2 antigen exposure (infection OR vaccinatino). Quantification of SARS-CoV-2 specific antibodies (IgG against nucleocapsid-antigen; IgG and IgM against receptor-binding-domain of S1-antigen)
2) cellular immunity 28-42d after SARS-CoV-2 antigen exposure (infectino OR exposure). Evaluation of SARS-CoV-2 antigen-specific t-cellular response by FACS-analysis
Secondary Outcome
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure, maximum of 10 measurements per patient, depending on availability
1) antibody-mediated immune response, same as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure
2) Evaluation of cellular immunity, same as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2021/03/23
- 150
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 5 Years
- no maximum age
Additional Inclusion Criteria
Arm 1: Kidney transplant recipients (de-novo or re-transplanted); kidney-pancreas transplant recipients (de-novo or re-transplanted); no active malignancy; ≥5 years of age.
Arm 2: patients without chronic kidney disease (>CKD Stadium 3b (GFR >45 ml/min/1.73m2)); no current immunosuppressive medication; no active malignancy; ≥5 years of age.
Arm 3: patients with renal disease without kidney transplantation; no active malignancy; ≥5 years of age.
Exclusion Criteria
No informed consent available; not meeting above mentioned eligibility criteria.
Addresses
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- Nierenzentrum Heidelberg
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 49 (0)6221/91120
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- Zentrum für Kinder- und Jugendmedizin
- Mr. Prof. Dr. med. Burkhard Tönshoff
- Im Neuenheimer Feld 430
- 69120 Heidelberg
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- +40 (0) 6221/568401
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- burkhard.toenshoff at med.uni-heidelberg.de
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- Zentrum für Kinder- und Jugendmedizin
- Mr. Dr. med. Maximilian Stich
- Im Neuenheimer Feld 430
- 69120 Heidelberg
- Germany
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- maximilian.stich at med.uni-heidelberg.de
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- Nierenzentrum Heidelberg, Universitätsklinikum Heidelberg
- Ms. Dr. med. Louise Benning
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
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- louise.benning at med.uni-heidelberg.de
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- Nierenzentrum Heidelberg
- Mr. Dr. med. Claudius Speer
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 (0) 6221/91120
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- claudius.speer at med.uni-heidelberg.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Nierenzentrum Heidelberg, Universitätsklinikum Heidelberg
- Ms. Dr. med. Louise Benning
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 06221-91120
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- louise.benning at med.uni-heidelberg.de
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end of 1:1-Block address contact public-contact -
start of 1:1-Block address public-contact
- Nierenzentrum Heidelberg
- Mr. Dr. med. Claudius Speer
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0) 6221/91120
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- claudius.speer at med.uni-heidelberg.de
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Sources of Monetary or Material Support
-
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- Nierenzentrum Heidelberg
- Im Neuenheimer Feld 162
- 69120 Heidelberg
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 49 (0)6221/91120
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- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Friedrichstraße 130 B
- 10117 Berlin
- Germany
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- http://www.bmbf.de
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- Dietmar Hopp Stiftung
- Opelstraße 28
- 68789 St.Leon-Rot
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0049 (0)6227 8608550
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- info at dietmar-hopp-stiftung.de
- http://www.dietmar-hopp-stiftung.de
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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