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

N/AActive Not RecruitingNCT05483725

Institute for Clinical and Experimental Medicine108 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

108

Conditions

Kidney Diseases Kidney Transplant; Complications COVID-19 Vaccine Adverse Reaction Rejection Acute Renal Rejection Chronic Renal

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Secondary Outcomes

Immunological effectiveness - anti-SARS-CoV-2 antibodies

Emergence or increase of anti-SARS-CoV-2 IgG.

Time frame: Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.