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

NCT04747522 | Active Not Recruiting

• 1 other identifier: 227626
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Infection; SARS-CoV Infection

Keywords

Vaccination; Humoral; Cellular

Outcome Measures

Primary Outcomes (2)

• Cellular immunological response

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

  1.5 months

• Humoral immunological response

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

  1.5 months

Secondary Outcomes (1)

• Vaccine related side effects

  6 months

Study Arms (2)

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

Healthy controls

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

Drug: SARS-CoV-2 vaccine

Interventions

SARS-CoV-2 vaccine DRUG

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

Healthy controls; Kidney Transplanted patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult, standard risk kidney transplanted patients on tacrolimus based immunosuppressive therapy are eligible for inclusion in the project. Adult, healthy Oslo university hospital (OUS) employees that receive vaccine as first line health care workers and that are not treated for any disease known to be a risk factor for severe COVID-19. These will be invited to participate via study information posted in the relevant clinics.

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Isolated blood cells DNA

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: January 22, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

NO (1)