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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: Completed Phase 1 study of Hepatitis B, sponsored by Baylor Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients will be followed for 60 weeks to capture adverse events. Safety will be determined by the proportion of patients with unsolicited adverse events after vaccine administration, the proportion of patients with serious adverse events, the proportion of patients with medically attended adverse events, the proportion of patients with potentially immune-mediated medical conditions, and the proportion of patients who need an increase in immune suppressive medication.
Conditions Studied
Interventions
- BIOLOGICAL Heplisav-B
Study Locations (1)
Texas
- Baylor Scott & White Research Institute - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 1 |
What the finished NCT04199715 record still lists
NCT04199715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04199715's enrollment target sits among peer trials
10 31st of 32 higher than 1 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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