End Stage Renal DiseaseNCT05387343
COVID Vaccine Immunity in Kidney Transplant Recipients
An observational study of End Stage Renal Disease and Kidney Transplant; Complications, run by University of Alabama at Birmingham.
Trial summary
50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Transplant; Complications
- What is being tested?
- Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: patients planning on having a renal transplant at the University of Alabama at Birmingham
Who may be able to join
- End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
- no prior transplant
- no known history of COVID infection
- had at least 2 doses of mRNA COVID vaccine
- undergoing transplantation at the University of Alabama at Birmingham
- multi-organ transplant allowed
Who cannot join
- active COVID infection
- participant is not vaccinated against COVID
About this study
50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
Read the detailed description
50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
- Being tested
- Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test
- Keywords
- COVID-19, kidney, kidney transplant, end stage renal disease, mRNA vaccine
- Medical subject headings
- Kidney Failure, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity TestDiagnostic test
Also called mRNA COVID vaccine
Boosters will be given after month 3 after transplant, and the 2nd booster will be given 3 months after the first.
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID spike protein Immunoglobulin G (IgG) and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: pre-transplant
COVID spike protein IgG and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: month 1
COVID spike protein IgG and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: month 3
COVID spike protein IgG and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: month 4
COVID spike protein IgG and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: month 6
COVID spike protein IgG and Tcell assay
transplant patient response to vaccine compared to response of patients not on immunosuppression
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: funding lost
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- ViraCor Laboratories
- Responsible party
- Principal investigator, Graham C. Towns, University of Alabama at Birmingham
- Investigators
- Graham C Towns, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387343
- Sponsor's protocol ID
- GCT2022.001
- Status last verified
- Oct 2022
- First submitted
- 19 May 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID Vaccine Immunity in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05387343
- Acronym / sponsor ID
- GCT2022.001
- Keywords
- COVID-19, kidney, kidney transplant, end stage renal disease, mRNA vaccine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding lost
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- ViraCor Laboratories
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 24 May 2022 (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.
50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
Detailed description
50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients planning on having a renal transplant at the University of Alabama at Birmingham
Key inclusion criteria (6 listed)
- End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
- no prior transplant
- no known history of COVID infection
- had at least 2 doses of mRNA COVID vaccine
- undergoing transplantation at the University of Alabama at Birmingham
Key exclusion criteria (2 listed)
- active COVID infection
- participant is not vaccinated against COVID
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 |
|---|---|---|
| Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity TestAlso: mRNA COVID vaccineBoosters will be given after month 3 after transplant, and the 2nd booster will be given 3 months after the first. | Diagnostic test | – |
Primary outcome
COVID spike protein Immunoglobulin G (IgG) and Tcell assay
Time frame: pre-transplant
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay
Time frame: month 1
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay
Time frame: month 3
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay
Time frame: month 4
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay
Time frame: month 6
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay
Time frame: month 12
transplant patient response to vaccine compared to response of patients not on immunosuppression
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Graham C Towns, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Kidney Transplant; Complications, run by University of Alabama at Birmingham.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
COVID spike protein Immunoglobulin G (IgG) and Tcell assay (time frame: pre-transplant). The study lists 6 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 28 Oct 2022.