Clinical trialNCT05077254CompletedPhase 2Interventional

COVID Protection After Transplant-Immunosuppression Reduction

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment48Kidney Transplant RecipientsLiver Transplant Recipients

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christian P. Larsen, MD, DPhil
Emory Transplant Center, Emory University School of Medicine
Study Chair
clinicaltrials.gov ↗
Dorry L. Segev, MD, PhD
Transplant Surgery, Johns Hopkins University School of Medicine
Study Chair
clinicaltrials.gov ↗
Peter S. Heeger, MD
Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California, San Diego
San Diego, California, United States
University of California San Francisco Health
San Francisco, California, United States
Emory Healthcare
Atlanta, Georgia, United States
University of Illinois Health
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
Ochsner Health
New Orleans, Louisiana, United States
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States
Mt. Sinai Hospital
New York, New York, United States
Nyu Langone Transplant Institute
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Houston Methodist
Houston, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Moderna COVID-19 Vaccine 2023-2024Pfizer-BioNTech COVID-19 Vaccine 2023-2024SOC IS ReductionSOC IS Regimen

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 6 Dec 2021
Primary completion: 28 Feb 2024
Completion: 21 Feb 2025
Last update posted: 23 Apr 2026
Registered enrollment: 48
Registry id: NCT05077254

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.