Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
NCT ID: NCT05156086
Last Updated: 2021-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2021-11-16
2022-11-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
COVID-19 vaccine, booster
Additional dose of COVID-19 vaccine (booster shot)
Interventions
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COVID-19 vaccine, booster
Additional dose of COVID-19 vaccine (booster shot)
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jongwon Ha
Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jongwon Ha, MD, PhD
Role: primary
Other Identifiers
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H2110-175-1266
Identifier Type: -
Identifier Source: org_study_id