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
Arm | Description | Assigned Intervention |
---|---|---|
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 |
|
Recruiting Locations
Sacramento, California 95817
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.