At a glance
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A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients
In Brief
A Phase 2 clinical trial evaluating Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024, and 2 other interventions for Kidney Transplant Recipients and Liver Transplant Recipients. Completed, enrolled 48 participants across 15 sites.
Detailed Summary
This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
Study Details
Timeline
Interventions
Administration: One dose administered intramuscularly.
Administration: One dose administered intramuscularly.
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.