Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

COVID-19 Immunosuppression Vaccine Response Impaired Antimetabolites Reduction in antimetabolite immunosuppression Immunosuppression reduction

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

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

Location

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05060991
Phase
Phase 4
Study Type
Interventional
Last Updated