Kidney TransplantationTASMANIANCT04832841
IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA)
An observational study of Kidney Transplantation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- anti-spike SARS-CoV-2 IgG
- Type of treatment
- Vaccines
- How many people
- 753 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Mar 2021to 30 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
Who may be able to join
- Kidney transplant recipients
- Recipient age ≥ 18 years
- Written Informed Consent and Consent for Processing Personal Data
- Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
Who cannot join
- Active SARS-CoV-2 infection.
- Patients that received anti-SARS-CoV-2 monoclonal antibodies.
- Active infection after vaccination
- Monoclonal antibodies treatment ahead of antibody or cellular immunity screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation
The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.
Read the detailed description
TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated:
- kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR)
- kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed
The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling.
In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay.
- Conditions
- Kidney Transplantation
- Being tested
- anti-spike SARS-CoV-2 IgG
- Keywords
- kidney transplantation, SARS-CoV-2, humoral immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-spike SARS-CoV-2 IgGDiagnostic test
Immunochemiluminescent assay by DiaSorin S.p.A. Italy
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 naive | Kidney transplant recipients without previous SARS-CoV-2 infection verified by absence of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. Receives: Diagnostic Test: anti-spike SARS-CoV-2 IgG | |
| SARS-Cov-2 exposed | Kidney transplant recipients with previous SARS-CoV-2 exposition verified by positivity of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. Receives: Diagnostic Test: anti-spike SARS-CoV-2 IgG | |
| Waiting list | Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed Receives: Diagnostic Test: anti-spike SARS-CoV-2 IgG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination
Measured: 15 days-90 days
Secondary outcomes (5)
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
anti-spike SARS-CoV-2 IgG measured 3 ≥ months after the first blood sampling
Measured: 3 months - 6 months
Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Cellular immunity measured by ELISPOT assay in subgroup of 50 patients
Measured: 15 - 90 days
Graft function after vaccination
Estimated glomerular filtration rate (eGFR)
Measured: 15 days-90 days
Clinical variables affecting antibody levels
Sex, previous SARS-CoV-2 infection, Age, Retransplantation, BMI, time from transplant, eGFR, diabetes mellitus, use of imunosuppression (tacrolimus, cyclosporine A, CNI-free regimen, mycophenolate mofetil, depleting therapy).
Measured: 15 days-90 days
The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination
Fried frailty score
Measured: 15 days-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start18 Mar 2021
- Primary completion30 Sep 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine
- Investigators
- Ondrej Viklicky, Prof., Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832841
- Sponsor's protocol ID
- G-21-07
- Acronym
- TASMANIA
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmalz M, Vankova H, Rajnochova-Bloudickova S, Hruba P, Fialova M, Gurka J, Magicova M, Striz I, Zahradka I, Viklicky O. The impact of frailty syndrome on humoral response to SARS-CoV-2 mRNA vaccines in older kidney transplant recipients. Int Urol Nephrol. 2023 Nov;55(11):2959-2965. doi: 10.1007/s11255-023-03557-6. Epub 2023 Apr 7.
PubMed 37027078Magicova M, Zahradka I, Fialova M, Neskudla T, Gurka J, Modos I, Hojny M, Raska P, Smejkal P, Striz I, Viklicky O. Determinants of Immune Response to Anti-SARS-CoV-2 mRNA Vaccines in Kidney Transplant Recipients: A Prospective Cohort Study. Transplantation. 2022 Apr 1;106(4):842-852. doi: 10.1097/TP.0000000000004044.
PubMed 34999659
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04832841
- Acronym / sponsor ID
- TASMANIA / G-21-07
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, SARS-CoV-2, humoral immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine.
Detailed description
TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated:
- kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR)
- kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed
The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling.
In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 naive | – | Diagnostic Test: anti-spike SARS-CoV-2 IgGKidney transplant recipients without previous SARS-CoV-2 infection verified by absence of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. |
| SARS-Cov-2 exposed | – | Diagnostic Test: anti-spike SARS-CoV-2 IgGKidney transplant recipients with previous SARS-CoV-2 exposition verified by positivity of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. |
| Waiting list | – | Diagnostic Test: anti-spike SARS-CoV-2 IgGKidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
Key inclusion criteria (4 listed)
- Kidney transplant recipients
- Recipient age ≥ 18 years
- Written Informed Consent and Consent for Processing Personal Data
- Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation.
Key exclusion criteria (4 listed)
- Active SARS-CoV-2 infection.
- Patients that received anti-SARS-CoV-2 monoclonal antibodies.
- Active infection after vaccination
- Monoclonal antibodies treatment ahead of antibody or cellular immunity screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-spike SARS-CoV-2 IgGImmunochemiluminescent assay by DiaSorin S.p.A. Italy | Diagnostic test | SARS-CoV-2 naive, SARS-Cov-2 exposed, Waiting list |
Primary outcome
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Time frame: 15 days-90 days
anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination
5 secondary outcomes
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Time frame: 3 months - 6 months
Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination.
Time frame: 15 - 90 days
Graft function after vaccination
Time frame: 15 days-90 days
Clinical variables affecting antibody levels
Time frame: 15 days-90 days
The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination
Time frame: 15 days-90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 37027078Schmalz M, Vankova H, Rajnochova-Bloudickova S, Hruba P, Fialova M, Gurka J, Magicova M, Striz I, Zahradka I, Viklicky O. The impact of frailty syndrome on humoral response to SARS-CoV-2 mRNA vaccines in older kidney transplant recipients. Int Urol Nephrol. 2023 Nov;55(11):2959-2965. doi: 10.1007/s11255-023-03557-6. Epub 2023 Apr 7.
- Derived from this study: PubMed 34999659Magicova M, Zahradka I, Fialova M, Neskudla T, Gurka J, Modos I, Hojny M, Raska P, Smejkal P, Striz I, Viklicky O. Determinants of Immune Response to Anti-SARS-CoV-2 mRNA Vaccines in Kidney Transplant Recipients: A Prospective Cohort Study. Transplantation. 2022 Apr 1;106(4):842-852. doi: 10.1097/TP.0000000000004044.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Viklicky, Prof. principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Mar 2024. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. (time frame: 15 days-90 days). 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 NCT04832841, which also lists 2 linked publications.
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 6 Mar 2024.