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COVID Protection After Transplant-Immunosuppression Reduction
NCT05077254 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BIOLOGICAL Pfizer-BioNTech COVID-19 Vaccine 2023-2024
- BIOLOGICAL Moderna COVID-19 Vaccine 2023-2024
- DRUG SOC IS Regimen
- DRUG SOC IS Reduction
Study Locations (15)
New York
- NYU Langone Transplant Institute — New York
- Mt. Sinai Hospital — New York
- Weill Cornell Medicine — New York
California
- University of California, San Diego — San Diego
- University of California San Francisco Health — San Francisco
Illinois
- University of Illinois Health — Chicago
- Northwestern University — Evanston
Pennsylvania
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
Georgia
- Emory Healthcare — Atlanta
Iowa
- University of Iowa Hospitals — Iowa City
Louisiana
- Ochsner Health — New Orleans
Maryland
- Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2025-02-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077254
The ClinicalTrials.gov registry entry for NCT05077254 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 4 interventions — of which Pfizer-BioNTech COVID-19 Vaccine 2023-2024 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05077254 reports 15 study locations spanning 10 distinct geographic areas — top geographies include New York, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05077254 about?
NCT05077254 is a clinical study titled "COVID Protection After Transplant-Immunosuppression Reduction". 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 immunosuppressi...
What is the current status of trial NCT05077254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-12-06. Estimated completion is 2025-02-21.
What conditions does trial NCT05077254 study?
This clinical trial studies the following conditions: Kidney Transplant Recipients, Liver Transplant Recipients. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05077254?
The interventions under investigation include: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 (BIOLOGICAL), Moderna COVID-19 Vaccine 2023-2024 (BIOLOGICAL), SOC IS Regimen (DRUG), SOC IS Reduction (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05077254?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05077254 being conducted?
This trial has 15 study locations across California, Georgia, Illinois, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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