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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
University of California, Davis
Sacramento, California, United States
RECRUITINGChange in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline
Time frame: 6 weeks after receipt of 3rd dose mRNA vaccine
Percentage of participants who achieve high-positive antibody titer
Time frame: 6 weeks after receipt of 3rd dose mRNA vaccine
Acute rejection
Time frame: 1 week to 16 weeks after intervention
De Novo donor specific antibody (DSA) development
Time frame: 4 week to 16 weeks after intervention
Change in donor-derived cell free DNA from baseline
Time frame: 1 week to 16 weeks after intervention
Change in glomerular filtration rate (GFR) from baseline
Time frame: 1 week to 16 weeks after intervention
Change in proteinuria from baseline
Time frame: 1 week to 16 weeks after intervention
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