COVID-19 VaccinationCoVaKTNCT05156086
Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
An observational study of COVID-19 Vaccination and Renal Transplant, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The current study is a noninterventional prospective study examining the efficacy of additional dosage of the coronavirus disease 2019 (COVID-19) vaccine in kidney transplant recipients (KTRs). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19 Vaccination, Renal Transplant
- What is being tested?
- COVID-19 vaccine, booster
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2021to 8 Nov 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant recipients fully vaccinated with standard dose(s) of COVID-19 vaccination
Who may be able to join
- Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
- Patients ≥ 12 years old
- Patients fully vaccinated with two standard doses of COVID-19 vaccination with the vector vaccine (AZD1222 of AstraZeneca) or the mRNA vaccines (BNT162b2 of Pfizer-BioNTech or mRNA-1273 of Moderna) including homologous and heterologous regimen.
- Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
- Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.
Who cannot join
- Patients with a previous history of SARS-CoV-2 infection
- Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
- Patients who restarted dialysis due to graft failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jongwon Ha, MD, PhD, +82-2-2072-2991, jwhamd@snu.ac.kr
About this study
Official title: Prospective Study on the Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
The current study is a noninterventional prospective study examining the efficacy of additional dosage of the coronavirus disease 2019 (COVID-19) vaccine in kidney transplant recipients (KTRs).
Read the detailed description
In this clinical, prospective, non-interventional study to assess the effectiveness of an additional dose of COVID-19 vaccination, we evaluated the seroconversion rate of KTRs after the booster shot. Consecutive individuals who have completed standard two-doses of COVID-19 vaccination were enrolled. Following consent, demographic and clinical data were collected from participants, including patient/ transplant characteristics and information regarding previous COVID-19 vaccination.
1 Study visit and sample collection Patients were invited to return for up to 2 follow-up visits for sample collection. Whole blood samples were collected two weeks to 1 day before the booster vaccination and 4 weeks after. During the visit for the second blood sample, a survey was conducted to assess booster-related adverse events.
- Anti-SARS-CoV-2 antibody assay IgG antibodies against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) were quantified with SARS-CoV-2 IgG II Quant assay (Abbott).
Additionally, neutralizing antibody was assessed using anti-SARS-CoV-2 GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit. The cPass detection kit utilizes the horseradish peroxidase (HRP) conjugated recombinant SARS-CoV-2 RBD protein and the human angiotensin-converting enzyme 2 (ACE2) receptor protein. It detects neutralizing antibodies capable of blocking protein interaction between HRP-RBD and ACE2. The assay was performed according to the manufacturer's instructions.
- Conditions
- COVID-19 Vaccination, Renal Transplant
- Being tested
- COVID-19 vaccine, booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine, boosterDrug
Additional dose of COVID-19 vaccine (booster shot)
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients with booster | Patients who received kidney-only transplant or multi-organ transplant including kidney and fully vaccinated with standard dose(s) of messenger RNA (mRNA) or vector vaccine Receives: Drug: COVID-19 vaccine, booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-SARS-CoV-2 IgG antibody seroconversion rate
Seroconversion rate calculated from the anti-SARS-CoV-2 IgG antibody positivity difference before and after the booster shot
Measured: 1 month after booster vaccination
adverse event related to booster shot
local and systemic adverse event related to the third dose of COVID-19 vaccine
Measured: 1 month after booster vaccination
Secondary outcomes (6)
Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine
Measured: 2week before booster vaccination
Rate of anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine
Measured: 1 month after booster vaccination
Change in the quantitative amount of IgG after additional third doses of COVID-19 vaccine
Measured: 1 month after booster vaccination
Rate of neutralization antibody positivity after standard 2-doses of COVID-19 vaccine
Measured: 2week before booster vaccination
Rate of neutralization antibody after additional third doses of COVID-19 vaccine
Measured: 1 month after booster vaccination
Rate of neutralization antibody seroconversion rate upon third doses of COVID-19 vaccine
Measured: 1 month after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start16 Nov 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion8 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongwon Ha, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156086
- Sponsor's protocol ID
- H2110-175-1266
- Acronym
- CoVaKT
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT05156086
- Acronym / sponsor ID
- CoVaKT / H2110-175-1266
- Conditions
- COVID-19 Vaccination, Renal Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 8 Nov 2022 (estimated)
- First posted
- 14 Dec 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.
The current study is a noninterventional prospective study examining the efficacy of additional dosage of the coronavirus disease 2019 (COVID-19) vaccine in kidney transplant recipients (KTRs).
Detailed description
In this clinical, prospective, non-interventional study to assess the effectiveness of an additional dose of COVID-19 vaccination, we evaluated the seroconversion rate of KTRs after the booster shot. Consecutive individuals who have completed standard two-doses of COVID-19 vaccination were enrolled. Following consent, demographic and clinical data were collected from participants, including patient/ transplant characteristics and information regarding previous COVID-19 vaccination.
1 Study visit and sample collection Patients were invited to return for up to 2 follow-up visits for sample collection. Whole blood samples were collected two weeks to 1 day before the booster vaccination and 4 weeks after. During the visit for the second blood sample, a survey was conducted to assess booster-related adverse events.
- Anti-SARS-CoV-2 antibody assay IgG antibodies against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) were quantified with SARS-CoV-2 IgG II Quant assay (Abbott).
Additionally, neutralizing antibody was assessed using anti-SARS-CoV-2 GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit. The cPass detection kit utilizes the horseradish peroxidase (HRP) conjugated recombinant SARS-CoV-2 RBD protein and the human angiotensin-converting enzyme 2 (ACE2) receptor protein. It detects neutralizing antibodies capable of blocking protein interaction between HRP-RBD and ACE2. The assay was performed according to the manufacturer's instructions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients with booster | – | Drug: COVID-19 vaccine, boosterPatients who received kidney-only transplant or multi-organ transplant including kidney and fully vaccinated with standard dose(s) of messenger RNA (mRNA) or vector vaccine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients fully vaccinated with standard dose(s) of COVID-19 vaccination
Key inclusion criteria (5 listed)
- Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
- Patients ≥ 12 years old
- Patients fully vaccinated with two standard doses of COVID-19 vaccination with the vector vaccine (AZD1222 of AstraZeneca) or the mRNA vaccines (BNT162b2 of Pfizer-BioNTech or mRNA-1273 of Moderna) including homologous and heterologous regimen.
- Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
- Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.
Key exclusion criteria (3 listed)
- Patients with a previous history of SARS-CoV-2 infection
- Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
- Patients who restarted dialysis due to graft failure
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 |
|---|---|---|
| COVID-19 vaccine, boosterAdditional dose of COVID-19 vaccine (booster shot) | Drug | Kidney transplant recipients with booster |
Primary outcome
anti-SARS-CoV-2 IgG antibody seroconversion rate
Time frame: 1 month after booster vaccination
Seroconversion rate calculated from the anti-SARS-CoV-2 IgG antibody positivity difference before and after the booster shot
adverse event related to booster shot
Time frame: 1 month after booster vaccination
local and systemic adverse event related to the third dose of COVID-19 vaccine
6 secondary outcomes
Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine
Time frame: 2week before booster vaccination
Rate of anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine
Time frame: 1 month after booster vaccination
Change in the quantitative amount of IgG after additional third doses of COVID-19 vaccine
Time frame: 1 month after booster vaccination
Rate of neutralization antibody positivity after standard 2-doses of COVID-19 vaccine
Time frame: 2week before booster vaccination
Rate of neutralization antibody after additional third doses of COVID-19 vaccine
Time frame: 1 month after booster vaccination
Rate of neutralization antibody seroconversion rate upon third doses of COVID-19 vaccine
Time frame: 1 month after booster vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 COVID-19 Vaccination and Renal Transplant, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jongwon Ha, MD, PhD (02-2072-2318, jwhamd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-SARS-CoV-2 IgG antibody seroconversion rate (time frame: 1 month after booster vaccination). 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 15 Dec 2021.