Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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
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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. 2. 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.

Official Title
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Prospective Study on the Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients

Conditions
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COVID-19 Vaccination, Renal Transplant

Intervention / Treatment
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* Drug: COVID-19 vaccine, booster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant recipients with booster<br>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<br>* Additional dose of COVID-19 vaccine (booster shot)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 month after booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |