Clinical trial

SARS-CoV-2 Cellular and Humoral Immune Response Following Vaccination of Kidney Transplant Recipients and Healthy Controls

Name
227626
Description
None of the vaccines approved, or in clinical trials, have so far been tested on transplanted patients. If they produce an immune response to the Spike protein of SARS-CoV-2 it is unknown how long the protective immunity will last. Not all immune responses are equal. The investigators will quantify immune cell subsets with flow and mass cytometry analyses to describe the phenotype of responding immune cells, including specific T cells. If not already established, patient human Leukocyte antigen (HLA) genotypes will be typed. In order to compare the immune responses with healthy individuals a control group of hospital employees will be included and sampled before and after vaccination according to the same time schedules as the kidney transplanted patients.
Trial arms
Trial start
2021-01-22
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Treatment
SARS-CoV-2 vaccine
SARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna
Arms:
Healthy controls, Kidney Transplanted patients
Size
150
Primary endpoint
Cellular immunological response
1.5 months
Humoral immunological response
1.5 months
Eligibility criteria
Inclusion Criteria: * Patients transplanted with a kidney (only) at least 6 months before vaccination OR healthy volunteer first line health care workers at OUS. * Age of 18 years or older (also for controls). * Standard immunological risk at transplantation (i.e. no donor specific HLA antibodies (DSA)) and not performed an ABO blood-type-incompatible transplantation. * No treatment for rejection episodes the last 6 months before inclusion. * Immunosuppressive therapy including tacrolimus, mycophenolate and prednisolone. * Stable graft-function the last 6 months. * S-creatinine \< 200 μmol/L (also for controls). * Signed informed consent to participate in the study (also for controls). Exclusion Criteria: * Three or more previous transplantations. * Hemoglobin level below 10 g/dL (also for control). * Leukopenia defined as total lymphocyte count \< 2 X 109 (also for controls). * Previous treatment with anti-thymocyte antibodies (ATG) or rituximab.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood Serum Isolated blood cells DNA'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

1 product

2 indications

Product
SARS-CoV-2
Indication
COVID-19