COVID-19 Clinical Trial
— ADIVKTOfficial title:
Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
Verified date | February 2022 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 24, 2023 |
Est. primary completion date | December 24, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | CareDx |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline | 6 weeks after receipt of 3rd dose mRNA vaccine | ||
Primary | Percentage of participants who achieve high-positive antibody titer | 6 weeks after receipt of 3rd dose mRNA vaccine | ||
Secondary | Acute rejection | 1 week to 16 weeks after intervention | ||
Secondary | De Novo donor specific antibody (DSA) development | 4 week to 16 weeks after intervention | ||
Secondary | Change in donor-derived cell free DNA from baseline | 1 week to 16 weeks after intervention | ||
Secondary | Change in glomerular filtration rate (GFR) from baseline | 1 week to 16 weeks after intervention | ||
Secondary | Change in proteinuria from baseline | 1 week to 16 weeks after intervention |
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