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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Sep 27, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how adjusting the medications that suppress the immune system (called immunosuppressants) can help kidney transplant recipients respond better to a third dose of the COVID-19 vaccine. People who have received a kidney transplant often have a weakened immune response, which means they may not develop enough protection from the vaccine. The study aims to see if temporarily reducing immunosuppression can improve their immune response and also to check if this reduction is safe for participants.

To be eligible for this trial, participants must be kidney transplant recipients who are at least six months post-transplant and currently taking specific immunosuppressive medications. They should also have a low or negative antibody level against COVID-19. Participants will be monitored throughout the study to assess both their vaccine response and any potential safety concerns related to the adjustment in their medication. This study is important because it may help improve vaccination outcomes for individuals who are at higher risk of severe illness from COVID-19.

Gender

ALL

Eligibility criteria

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