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

Running, not enrolling · Phase 4

Conditions studied: COVID-19, Immunosuppression, Vaccine Response Impaired

In brief

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.

Key facts

Study ID

NCT05060991

Run by

University of California, Davis

People needed

14

Starts

2021-09-24

Expected to finish

2026-12-24

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to give informed consent for participation in the study
• First or repeat kidney transplant recipient
• Negative or low positive antibody titer on SARS-CoV-2 antibody assay
• On a mycophenolate or azathioprine based immunosuppressive regimen
• > 6 months post-transplant

You may not qualify if…

• Pregnancy
• Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)

Where it is running

• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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