Clinical trial

Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.

Name

G-21-71

Description

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.

Trial arms

Trial start

2021-10-04

Estimated PCD

2024-12-04

Trial end

2024-12-31

Status

Active (not recruiting)

Treatment

Booster dose of mRNA vaccine

Administration of SARS-CoV-2 mRNA vaccine.

Arms:

First booster dose group

Size

108

Primary endpoint

Immunological safety - anti-HLA antibodies

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

Immunological safety - donor-derived cell-free DNA

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples, four 5ml vials of blood, taken on day of booster dose and 3 months later.'}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}

Updated at

2024-03-06

1 organization

1 product

6 indications

Organization

Institute for Clinical and Experimental Medicine

Product

mRNA vaccine booster dose

Indication

Kidney Diseases

Indication