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

Purpose

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.

Conditions

  • COVID-19
  • Immunosuppression
  • Vaccine Response Impaired

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Prospective randomized open-labeled
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Immunosuppression reduction 		Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine
  • Drug: Reduction in antimetabolite immunosuppression
    Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
No Intervention
Standard of care 		No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine

Recruiting Locations

University of California, Davis
Sacramento, California 95817
Contact:
Amanpreet Kaur
916-734-4009
axkaur@ucdavis.edu

More Details

NCT ID
NCT05060991
Status
Recruiting
Sponsor
University of California, Davis

Detailed Description

This is a prospective, randomized open-labeled study of kidney transplant recipients who have previously received two doses of mRNA COVID-19 vaccine (either BNT162b2, Pfizer-BioNTech or mRNA-1273, Moderna) and who are eligible to receive a 3rd dose of mRNA vaccine.