Kidney DiseasesNCT05483725
Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
An observational study of Kidney Diseases and Kidney Transplant; Complications, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Kidney Transplant; Complications, COVID-19
- What is being tested?
- Booster dose of mRNA vaccine
- Type of treatment
- Vaccines
- How many people
- 108 participants
- Where
- 1 siteCzechia
- Study dates
- 4 Oct 2021to 31 Dec 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Kidney transplant recipients, vaccinated with 2 doses of mRNA vaccines against COVID, scheduled for the first booster dose.
Who may be able to join
- Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
- vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
- immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
- COVID naive
Who cannot join
- age < 18 years
- pregnant women, breastfeeding women
- unable/unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.
- Conditions
- Kidney Diseases, Kidney Transplant; Complications, COVID-19, Vaccine Adverse Reaction, Rejection Acute Renal, Rejection Chronic Renal
- Being tested
- Booster dose of mRNA vaccine
- Keywords
- kidney transplantation, COVID-19, mRNA vaccine, vaccine safety, alloreactivity
- Medical subject headings
- Kidney Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booster dose of mRNA vaccineBiological
Administration of SARS-CoV-2 mRNA vaccine.
| Study group | Role | What they receive |
|---|---|---|
| First booster dose group | Not described Receives: Biological: Booster dose of mRNA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological safety - anti-HLA antibodies
Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Measured: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Immunological safety - donor-derived cell-free DNA
Elevation of dd-cfDNA above 1% threshold
Measured: Comparison of dd-cfDNA assays at booster dose and three months later.
Secondary outcomes (1)
Immunological effectiveness - anti-SARS-CoV-2 antibodies
Emergence or increase of anti-SARS-CoV-2 IgG.
Measured: Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start4 Oct 2021
- Primary completion4 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 DiseasesStudies 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
- 108 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, MD, PhD, Principal investigator, Head of Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483725
- Sponsor's protocol ID
- G-21-71
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petr V, Zahradka I, Modos I, Roder M, Fialova M, Machkova J, Kabrtova K, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine Booster Doses in Kidney Transplant Recipients: Results of a 12-mo Follow-up From a Prospective Observational Study. Transplant Direct. 2024 May 17;10(6):e1645. doi: 10.1097/TXD.0000000000001645. eCollection 2024 Jun.
PubMed 38769974Petr V, Zahradka I, Modos I, Roder M, Prewett A, Fialova M, Machkova J, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. First Booster of SARS-COV-2 mRNA Vaccine Is Not Associated With Alloimmunization and Subclinical Injury of Kidney Allograft. Transplantation. 2023 Feb 1;107(2):e62-e64. doi: 10.1097/TP.0000000000004421. Epub 2022 Oct 29. No abstract available.
PubMed 36314999
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
- Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.
- ClinicalTrials.gov ID
- NCT05483725
- Acronym / sponsor ID
- G-21-71
- Conditions
- Kidney Diseases, Kidney Transplant; Complications, COVID-19, Vaccine Adverse Reaction, Rejection Acute Renal, Rejection Chronic Renal
- Keywords
- kidney transplantation, COVID-19, mRNA vaccine, vaccine safety, alloreactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 4 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Aug 2022 (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.
Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First booster dose group | – | Biological: Booster dose of mRNA vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients, vaccinated with 2 doses of mRNA vaccines against COVID, scheduled for the first booster dose.
Key inclusion criteria (4 listed)
- Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
- vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
- immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
- COVID naive
Key exclusion criteria (3 listed)
- age < 18 years
- pregnant women, breastfeeding women
- unable/unwilling to give informed consent
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 |
|---|---|---|
| Booster dose of mRNA vaccineAdministration of SARS-CoV-2 mRNA vaccine. | Biological | First booster dose group |
Primary outcome
Immunological safety - anti-HLA antibodies
Time frame: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.
Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Immunological safety - donor-derived cell-free DNA
Time frame: Comparison of dd-cfDNA assays at booster dose and three months later.
Elevation of dd-cfDNA above 1% threshold
1 secondary outcome
Immunological effectiveness - anti-SARS-CoV-2 antibodies
Time frame: Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 38769974Petr V, Zahradka I, Modos I, Roder M, Fialova M, Machkova J, Kabrtova K, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine Booster Doses in Kidney Transplant Recipients: Results of a 12-mo Follow-up From a Prospective Observational Study. Transplant Direct. 2024 May 17;10(6):e1645. doi: 10.1097/TXD.0000000000001645. eCollection 2024 Jun.
- Derived from this study: PubMed 36314999Petr V, Zahradka I, Modos I, Roder M, Prewett A, Fialova M, Machkova J, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. First Booster of SARS-COV-2 mRNA Vaccine Is Not Associated With Alloimmunization and Subclinical Injury of Kidney Allograft. Transplantation. 2023 Feb 1;107(2):e62-e64. doi: 10.1097/TP.0000000000004421. Epub 2022 Oct 29. No abstract available.
- Individual participant dataSharing planned: No
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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, MD, PhD principal investigator
Head of Department of Nephrology
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 Diseases and Kidney Transplant; Complications, 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 3 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 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?
Results are not available in the source record.
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?
Immunological safety - anti-HLA antibodies (time frame: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.). The study lists 2 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 NCT05483725, 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.