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ACTIVE NOT RECRUITING
NCT05060991
PHASE4

Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

Sponsor: University of California, Davis

View on ClinicalTrials.gov

Summary

Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.

Official title: Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2021-09-24

Completion Date

2026-12-24

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Reduction in antimetabolite immunosuppression

Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination

Locations (1)

University of California, Davis

Sacramento, California, United States