RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2021-09-24
Study Completion:2025-01-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05060991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is willing and able to give informed consent for participation in the study
  2. * First or repeat kidney transplant recipient
  3. * Negative or low positive antibody titer on SARS-CoV-2 antibody assay
  4. * On a mycophenolate or azathioprine based immunosuppressive regimen
  5. * \> 6 months post-transplant
  1. * Pregnancy
  2. * Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)

Contacts and Locations

Study Locations (Sites)

University of California, Davis
Sacramento, California, 95817
United States

Collaborators and Investigators

Sponsor: University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-24
Study Completion Date2025-01-24

Study Record Updates

Study Start Date2021-09-24
Study Completion Date2025-01-24

Terms related to this study

Additional Relevant MeSH Terms

  • COVID-19
  • Immunosuppression
  • Vaccine Response Impaired