SCV-KTx-imm: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19)

Oslo University Hospital (Other)
Overall Status
Active, not recruiting ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SARS-CoV-2 vaccine

Detailed Description

Kidney transplanted patients with post-transplant follow-up visits at the national transplant center in Norway will be included before they are SARS-CoV-2 vaccinated. As a control group the investigators will include blood samples from healthy volunteers (hospital employees) that receive vaccine as first line health care workers.

Baseline blood samples will be obtained before vaccination. The vaccination will be performed according to the national procedures and not necessarily by the hospital. Following vaccination, all patients and controls will have blood drawn 7-10 days as well as 4-6 weeks after the second dose. Depending on the results of the immunity testing the patients and controls may be invited to additional blood sampling up or at specific time points to two years following vaccination.

At each blood sampling and at the time of both vaccinations the systemic exposure of tacrolimus will be assessed in kidney transplanted patients.

All samples will be analyzed with validated assays for SARS-CoV-2 immunoglobulin G (IgG) (anti-receptor binding domain (RBD) spike protein) using ELISA, flow cytometry bead arrays and SARS-CoV-2 neutralization assays or comparable techniques. Cells will be analyzed by flow and mass cytometry for activation and phenotype markers, and with functional assays for responsiveness (e.g. proliferation and cytokine production). Samples will be HLA-typed if HLA-genotype if not already established.

Study Design

Study Type:
Anticipated Enrollment :
150 participants
Observational Model:
Time Perspective:
Official Title:
SARS-CoV-2 Cellular and Humoral Immune Response Following Vaccination of Kidney Transplant Recipients and Healthy Controls
Actual Study Start Date :
Jan 22, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Kidney Transplanted patients

Kidney transplanted patients transplanted at least 6 months prior to SARS-CoV-2 vaccination. Vaccination according to national plan with messenger Ribonucleic acid (mRNA) vaccine

Drug: SARS-CoV-2 vaccine
SARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna

Healthy controls

Healthy hospital staff receiving SARS-CoV-2 mRNA vaccine as being front line Healthcare workers.

Drug: SARS-CoV-2 vaccine
SARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna

Outcome Measures

Primary Outcome Measures

  1. Cellular immunological response [1.5 months]

    IgG antibodies against SARS-CoV-2 spike protein above assay limit of positive sample.

  2. Humoral immunological response [1.5 months]

    T-cell reactivity against SARS-CoV-2 spike protein, including known mutation in the spike protein.

Secondary Outcome Measures

  1. Vaccine related side effects [6 months]

    Adverse drug reactions that have a reasonable relation to the vaccination, as assessed by the investigator

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations


Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

  • Oslo University Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Anders Åsberg, Head of Laboratory, Oslo University Hospital Identifier:
Other Study ID Numbers:
  • 227626
First Posted:
Feb 10, 2021
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by Anders Åsberg, Head of Laboratory, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022