Clinical trial NCT05060991: Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
Official title: Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: COVID-19
Immunosuppression
Vaccine Response Impaired
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: CareDx
First posted: 2021-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized open-labeled
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline
timeFrame: 6 weeks after receipt of 3rd dose mRNA vaccine
measure: Percentage of participants who achieve high-positive antibody titer
timeFrame: 6 weeks after receipt of 3rd dose mRNA vaccine
Secondary outcomes:
measure: Acute rejection
timeFrame: 1 week to 16 weeks after intervention
measure: De Novo donor specific antibody (DSA) development
timeFrame: 4 week to 16 weeks after intervention
measure: Change in donor-derived cell free DNA from baseline
timeFrame: 1 week to 16 weeks after intervention
measure: Change in glomerular filtration rate (GFR) from baseline
timeFrame: 1 week to 16 weeks after intervention
measure: Change in proteinuria from baseline
timeFrame: 1 week to 16 weeks after intervention
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
References: