Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
NCT ID: NCT05483725
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
108 participants
OBSERVATIONAL
2021-10-04
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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First booster dose group
Booster dose of mRNA vaccine
Administration of SARS-CoV-2 mRNA vaccine.
Interventions
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Booster dose of mRNA vaccine
Administration of SARS-CoV-2 mRNA vaccine.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* pregnant women, breastfeeding women
* unable/unwilling to give informed consent
18 Years
ALL
No
Sponsors
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Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Prof. Ondřej Viklický, M.D., Ph.D.
Head of the Transplant Center, Head of the Department of Nephrology, Principle Investigator, Clinical Professor
Principal Investigators
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Ondrej Viklicky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Head of Department of Nephrology
Locations
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Institute for Clinical and Experimental Medicine
Prague, , Czechia
Countries
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References
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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.
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.
Other Identifiers
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G-21-71
Identifier Type: -
Identifier Source: org_study_id
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