Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
University of California, Davis
50 participants
Sep 24, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria2
- Pregnancy
- Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)
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Interventions
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05060991