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

SARS-CoV Infection Clinical Trial

— SCV-KTx-imm  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04747522
• Other study ID #: 227626
• Status: Active, not recruiting
• Start date: January 22, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Kidney Transplant Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular immunological response	IgG antibodies against SARS-CoV-2 spike protein above assay limit of positive sample.	1.5 months
Primary	Humoral immunological response	T-cell reactivity against SARS-CoV-2 spike protein, including known mutation in the spike protein.	1.5 months
Secondary	Vaccine related side effects	Adverse drug reactions that have a reasonable relation to the vaccination, as assessed by the investigator	6 months