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COVID Protection After Transplant-Immunosuppression Reduction

NCT05077254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-23

Study results available
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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.

Conditions

  • Kidney Transplant Recipients
  • Liver 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.

Sponsors & Collaborators

  • New York University Langone Health

    collaborator UNKNOWN

  • Johns Hopkins University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Dorry L. Segev, MD, PhD · Transplant Surgery, Johns Hopkins University School of Medicine

  • Peter S. Heeger, MD · Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai

  • Christian P. Larsen, MD, DPhil · Emory Transplant Center, Emory University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2024-02-28
Completion
2025-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077254 on ClinicalTrials.gov