CoVaKT: Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: COVID-19 vaccine, booster
Additional dose of COVID-19 vaccine (booster shot)
|
Outcome Measures
Primary Outcome Measures
- anti-SARS-CoV-2 IgG antibody seroconversion rate [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 [1 month after booster vaccination]
local and systemic adverse event related to the third dose of COVID-19 vaccine
Secondary Outcome Measures
- Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine [2week before booster vaccination]
- Rate of anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine [1 month after booster vaccination]
- Change in the quantitative amount of IgG after additional third doses of COVID-19 vaccine [1 month after booster vaccination]
- Rate of neutralization antibody positivity after standard 2-doses of COVID-19 vaccine [2week before booster vaccination]
- Rate of neutralization antibody after additional third doses of COVID-19 vaccine [1 month after booster vaccination]
- Rate of neutralization antibody seroconversion rate upon third doses of COVID-19 vaccine [1 month after booster vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
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Patients ≥ 12 years old
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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.
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Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
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Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.
Exclusion Criteria:
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Patients with a previous history of SARS-CoV-2 infection
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Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
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Patients who restarted dialysis due to graft failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H2110-175-1266