UnknownNot Applicable

Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

Czechia108 participantsStarted 2021-10-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * age \< 18 years * pregnant women, breastfeeding women * unable/unwilling to give informed consent

What they're measuring

Immunological safety - anti-HLA antibodies

Timeframe: Comparison of anti-HLA single antigen bead assays at booster dose and three months later.

Immunological safety - donor-derived cell-free DNA

Timeframe: Comparison of dd-cfDNA assays at booster dose and three months later.

Trial details

NCT IDNCT05483725

SponsorInstitute for Clinical and Experimental Medicine

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Kidney Diseases trials