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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05483725

Enrollment

108

Registered

2022-08-02

Start date

2021-10-04

Completion date

2024-12-31

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

kidney transplantation, COVID-19, mRNA vaccine, vaccine safety, alloreactivity

Brief 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.

Interventions

BIOLOGICALBooster dose of mRNA vaccine

Administration of SARS-CoV-2 mRNA vaccine.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Immunological safety - anti-HLA antibodies	Comparison of anti-HLA single antigen bead assays at booster dose and three months later.	Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.
Immunological safety - donor-derived cell-free DNA	Comparison of dd-cfDNA assays at booster dose and three months later.	Elevation of dd-cfDNA above 1% threshold

Secondary

Measure	Time frame	Description
Immunological effectiveness - anti-SARS-CoV-2 antibodies	Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.	Emergence or increase of anti-SARS-CoV-2 IgG.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026