Kidney Transplant InfectionSCV-KTx-immNCT04747522
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Immune Kidney Transplant Study (COVID-19)
An observational study of Kidney Transplant Infection and SARS-CoV Infection, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection, SARS-CoV Infection
- What is being tested?
- SARS-CoV-2 vaccine
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 22 Jan 2021to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 Cellular and Humoral Immune Response Following Vaccination of Kidney Transplant Recipients and Healthy Controls
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.
Read the 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.
- Conditions
- Kidney Transplant Infection, SARS-CoV Infection
- Being tested
- SARS-CoV-2 vaccine
- Keywords
- Vaccination, Humoral, Cellular
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccineDrug
SARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SARS-CoV-2 vaccine | |
| Healthy controls | Healthy hospital staff receiving SARS-CoV-2 mRNA vaccine as being front line Healthcare workers. Receives: Drug: SARS-CoV-2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular immunological response
IgG antibodies against SARS-CoV-2 spike protein above assay limit of positive sample.
Measured: 1.5 months
Humoral immunological response
T-cell reactivity against SARS-CoV-2 spike protein, including known mutation in the spike protein.
Measured: 1.5 months
Secondary outcomes (1)
Vaccine related side effects
Adverse drug reactions that have a reasonable relation to the vaccination, as assessed by the investigator
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start22 Jan 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Åsberg, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747522
- Sponsor's protocol ID
- 227626
- Acronym
- SCV-KTx-imm
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Potential sharing of de-identified immunological data. Need specific ethical Committee approval for sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Cellular and Humoral Immune Response Following Vaccination of Kidney Transplant Recipients and Healthy Controls
- ClinicalTrials.gov ID
- NCT04747522
- Acronym / sponsor ID
- SCV-KTx-imm / 227626
- Conditions
- Kidney Transplant Infection, SARS-CoV Infection
- Keywords
- Vaccination, Humoral, Cellular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplanted patients | – | Drug: SARS-CoV-2 vaccineKidney transplanted patients transplanted at least 6 months prior to SARS-CoV-2 vaccination. Vaccination according to national plan with messenger Ribonucleic acid (mRNA) vaccine |
| Healthy controls | – | Drug: SARS-CoV-2 vaccineHealthy hospital staff receiving SARS-CoV-2 mRNA vaccine as being front line Healthcare workers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 vaccineSARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna | Drug | Healthy controls, Kidney Transplanted patients |
Primary outcome
Cellular immunological response
Time frame: 1.5 months
IgG antibodies against SARS-CoV-2 spike protein above assay limit of positive sample.
Humoral immunological response
Time frame: 1.5 months
T-cell reactivity against SARS-CoV-2 spike protein, including known mutation in the spike protein.
1 secondary outcome
Vaccine related side effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. Potential sharing of de-identified immunological data. Need specific ethical Committee approval for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Infection and SARS-CoV Infection, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular immunological response (time frame: 1.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.