Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05156086
Other study ID # H2110-175-1266
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00820469 - Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab Phase 4
Completed NCT00239005 - Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation Phase 4
Completed NCT00270153 - The Use of ACE Inhibitors in the Early Renal Post-transplant Period Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT01256294 - Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients Phase 4
Suspended NCT01059292 - TIPE2 Associated With Kidney Transplant N/A
Completed NCT00547040 - Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Suspended NCT03043339 - Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
Completed NCT02581644 - Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries N/A
Completed NCT01728012 - Long-term Cardiovascular Risk Following Successful Renal Transplantation N/A
Terminated NCT01011114 - Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant N/A
Completed NCT00555373 - Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression N/A
Completed NCT02117596 - Calcineurin Inhibitor Based Immunosuppression Withdrawal N/A
Completed NCT01334333 - Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients Phase 4
Recruiting NCT03107858 - The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function Phase 2/Phase 3
Completed NCT00352547 - Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation N/A
Withdrawn NCT01244659 - A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment Phase 3