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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First booster dose group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Booster dose of mRNA vaccine | Biological | Administration of SARS-CoV-2 mRNA vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Comparison of dd-cfDNA assays at booster dose and three months later. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological effectiveness - anti-SARS-CoV-2 antibodies | Emergence or increase of anti-SARS-CoV-2 IgG. | Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant recipients, vaccinated with 2 doses of mRNA vaccines against COVID, scheduled for the first booster dose.
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| Name | Affiliation | Role |
|---|---|---|
| Ondrej Viklicky, MD, PhD | Head of Department of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 14021 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38769974 | Derived | 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. | |
| 36314999 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2025 | |
| Reset | May 14, 2025 |
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Serum samples, four 5ml vials of blood, taken on day of booster dose and 3 months later.
| Derived |
| Petr 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2025 | May 14, 2025 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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