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COMPLETED Phase 1

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

NCT04199715 · View on ClinicalTrials.gov ↗

Study Summary

This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is to test the safety of this vaccine in patients taking immune suppressive medicines.

Conditions Studied

Interventions

  • BIOLOGICAL Heplisav-B

Study Locations (1)

Texas

  • Baylor Scott & White Research Institute — Dallas

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-12-03
Est. Completion 2022-01-20
Phase Phase 1

Sponsor

Baylor Research Institute

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04199715

The ClinicalTrials.gov registry entry for NCT04199715 describes a study currently listed as completed. It is categorized as Phase 1, 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 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 65 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 Hepatitis B appearing as the primary indexed condition, and to 1 intervention — of which Heplisav-B 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: NCT04199715 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. 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 NCT04199715 about?

NCT04199715 is a clinical study titled "Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients". This is a preliminary trial of a Hepatitis B vaccine (Heplisav-B) in medically immunosuppressed patients. The purpose of this study is to test the ability of Heplisav-B to produce high levels of antibody that neutralize the virus and prevent hepatitis B from coming back. Another important purpose is...

What is the current status of trial NCT04199715?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-12-03. Estimated completion is 2022-01-20.

What conditions does trial NCT04199715 study?

This clinical trial studies the following conditions: Hepatitis B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04199715?

The interventions under investigation include: Heplisav-B (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04199715?

This trial is sponsored by Baylor Research Institute, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04199715 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial