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

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.

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