COVID Protection After Transplant-Immunosuppression Reduction

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 6, 2021

Primary Completion Date

February 28, 2024

Study Completion Date

February 21, 2025

Conditions
Kidney Transplant RecipientsLiver Transplant Recipients
Interventions
BIOLOGICAL

Pfizer-BioNTech COVID-19 Vaccine 2023-2024

Administration: One dose administered intramuscularly.

BIOLOGICAL

Moderna COVID-19 Vaccine 2023-2024

Administration: One dose administered intramuscularly.

DRUG

SOC IS Regimen

Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.

DRUG

SOC IS Reduction

Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.

Trial Locations (15)

10016

NYU Langone Transplant Institute, New York

10029

Mt. Sinai Hospital, New York

10065

Weill Cornell Medicine, New York

15260

University of Pittsburgh, Pittsburgh

19104

University of Pennsylvania, Philadelphia

21287

Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit, Baltimore

30322

Emory Healthcare, Atlanta

52242

University of Iowa Hospitals, Iowa City

53706

University of Wisconsin-Madison, Madison

60208

Northwestern University, Evanston

60612

University of Illinois Health, Chicago

70121

Ochsner Health, New Orleans

77030

Houston Methodist, Houston

92093

University of California, San Diego, San Diego

94143

University of California San Francisco Health, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

collaborator

Johns Hopkins University

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH