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

NCT05156086 | Unknown DMC FDA Drug

• 1 other identifier: H2110-175-1266
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19 Vaccination; Renal Transplant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (1)

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

Interventions

COVID-19 vaccine, booster DRUG

Additional dose of COVID-19 vaccine (booster shot)

Kidney transplant recipients with booster

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Interventions

COVID-19 vaccine booster shot

Central Study Contacts

Jongwon Ha, MD, PhD

CONTACT

02-2072-2318; jwhamd@snu.ac.kr

Ahram Han, MD

CONTACT

02-2072-2318; ahramh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 14, 2021
• Study Start: November 16, 2021
• Primary Completion: August 1, 2022
• Study Completion: November 8, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

KR (1)