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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2025-12-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Immunosuppression Vaccine Response Impaired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized open-labeled

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immunosuppression reduction

Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine

Group Type EXPERIMENTAL

Reduction in antimetabolite immunosuppression

Intervention Type DRUG

Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination

Standard of care

No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reduction in antimetabolite immunosuppression

Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination

Intervention Type DRUG

Eligibility Criteria

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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