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

Renal Transplant Clinical Trial

— CoVaKT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156086
• Other study ID #: H2110-175-1266
• Status: Recruiting
• Start date: November 16, 2021
• Est. completion date: November 8, 2022

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: Jongwon Ha, MD, PhD
• Phone: 02-2072-2318
• Email: jwhamd[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 8, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Renal Transplant

Intervention

Drug:
• COVID-19 vaccine, booster
Additional dose of COVID-19 vaccine (booster shot)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine		2week before booster vaccination
Secondary	Rate of anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine		1 month after booster vaccination
Secondary	Change in the quantitative amount of IgG after additional third doses of COVID-19 vaccine		1 month after booster vaccination
Secondary	Rate of neutralization antibody positivity after standard 2-doses of COVID-19 vaccine		2week before booster vaccination
Secondary	Rate of neutralization antibody after additional third doses of COVID-19 vaccine		1 month after booster vaccination
Secondary	Rate of neutralization antibody seroconversion rate upon third doses of COVID-19 vaccine		1 month after booster vaccination