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

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).

Study Overview

• Status: Recruiting
• Conditions: Renal Transplant; COVID-19 Vaccination
• Intervention / Treatment: Drug: COVID-19 vaccine, booster

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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jongwon Ha, MD, PhD; Phone Number: 02-2072-2318; Email: jwhamd@snu.ac.kr
• Study Contact Backup: Name: Ahram Han, MD; Phone Number: 02-2072-2318; Email: ahramh@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jongwon Ha, MD, PhD; Phone Number: +82-2-2072-2991; Email: jwhamd@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients fully vaccinated with standard dose(s) of COVID-19 vaccination

Description

Inclusion Criteria:

1. Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
2. Patients ≥ 12 years old
3. 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.
4. Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
5. Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.

Exclusion Criteria:

1. Patients with a previous history of SARS-CoV-2 infection
2. Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
3. Patients who restarted dialysis due to graft failure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): November 8, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: H2110-175-1266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No