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

Who is this study for? Patients with Covid19
What treatments are being studied? Reduction in Antimetabolite Immunosuppression
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, Davis
RECRUITING
Sacramento
Time Frame
Start Date: 2021-09-24
Estimated Completion Date: 2025-12-24
Participants
Target number of participants: 50
Treatments
Experimental: Immunosuppression reduction
Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
No_intervention: Standard of care
No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine
Related Therapeutic Areas
Sponsors
Collaborators: CareDx
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov