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A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants
NCT04860297 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.
Conditions Studied
Interventions
- BIOLOGICAL mRNA-1273
Study Locations (15)
Massachusetts
- Brigham and Women's Hospital — Boston
- University of Massachusetts Medical School — Worcester
New York
- Northwell Health — Manhasset
- Colombia University Medical Center — New York
Ohio
- University of Cincinnati — Cincinnati
- Cleveland Clinic Hospital — Cleveland
Arizona
- Aventiv Research Inc — Mesa
California
- California Institute of Renal Research — San Diego
Connecticut
- Yale University School of Medicine — New Haven
Florida
- Tampa General Medical Group — Tampa
Georgia
- Piedmont Transplant Institute — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2021-04-16 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04860297
The ClinicalTrials.gov registry entry for NCT04860297 describes a study currently listed as completed. It is categorized as Phase 3, 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 234 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with SARS-CoV-2 appearing as the primary indexed condition, and to 1 intervention — of which mRNA-1273 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: NCT04860297 reports 15 study locations spanning 12 distinct geographic areas — top geographies include Massachusetts, New York, Ohio. 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 NCT04860297 about?
NCT04860297 is a clinical study titled "A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants". This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to ...
What is the current status of trial NCT04860297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 234 participants. The study started on 2021-04-16. Estimated completion is 2023-05-22.
What conditions does trial NCT04860297 study?
This clinical trial studies the following conditions: SARS-CoV-2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04860297?
The interventions under investigation include: mRNA-1273 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04860297?
This trial is sponsored by ModernaTX, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04860297 being conducted?
This trial has 15 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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