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NCT04199715 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients

A Phase 1 study of Hepatitis B, sponsored by Baylor Research Institute.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT04199715 is a Phase 1 study of Hepatitis B that has completed, run by Baylor Research Institute. The registered enrollment target is 10 participants, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04199715, a Phase 1 study of Hepatitis B, has completed, sponsored by Baylor Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

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

Hepatitis B

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

180 total trials

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What the Registry Record Tells You About NCT04199715

The ClinicalTrials.gov registry entry for NCT04199715 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower). The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.

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.

NCT04199715 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

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.

What interventions are being tested in trial NCT04199715?

The interventions under investigation include: Heplisav-B (BIOLOGICAL).

Who is sponsoring clinical trial NCT04199715?

This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.