COVID-19 Vaccination, Renal Transplant
Conditions
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).
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.
Interventions
DRUGCOVID-19 vaccine, booster
Additional dose of COVID-19 vaccine (booster shot)
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 anti-SARS-CoV-2 IgG positivity after additional third doses of COVID-19 vaccine | 1 month after booster vaccination |
| Rate of anti-SARS-CoV-2 IgG positivity after standard 2-doses of COVID-19 vaccine | 2week before booster vaccination |
| Rate of neutralization antibody seroconversion rate upon 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 |
Countries
South Korea
Contacts
Primary ContactJongwon Ha, MD, PhD
Backup ContactAhram Han, MD
Outcome results
None listed