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NCT04843852 · ClinicalTrials.gov registry record · Phase 1
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
A Phase 1 study of Hepatitis B and Chronic Hepatitis B, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04843852: Recruiting Phase 1 study of Hepatitis B and Chronic Hepatitis B, sponsored by University of Maryland, Baltimore.
NCT04843852 is a Phase 1 study of Hepatitis B and Chronic Hepatitis B that is actively recruiting participants, run by University of Maryland, Baltimore. 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
NCT04843852, a Phase 1 study of Hepatitis B and Chronic Hepatitis B, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people with chronic hepatitis B? 2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B? 3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B? Participants will: * Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections. * Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months. * Be asked if they are having any side effects from HEPLISAV-B. * Have blood samples collected.
Primary Outcome
Number of local and systemic solicited adverse events
Conditions Studied
Interventions
- DRUG Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
Study Locations (1)
Maryland
- Institute of Human Virology, University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-10-16 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 1 |
What NCT04843852 shows while recruiting
NCT04843852 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 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 1 intervention - of which Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] is the first listed.
NCT04843852 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04843852 about?
NCT04843852 is a clinical study titled "TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B". The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are: 1. Is HEPLISAV-B safe in people...
What is the current status of trial NCT04843852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-10-16. Estimated completion is 2027-04-01.
What conditions does trial NCT04843852 study?
This clinical trial studies the following conditions: Hepatitis B, Chronic Hepatitis B.
What interventions are being tested in trial NCT04843852?
The interventions under investigation include: Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B] (DRUG).
Who is sponsoring clinical trial NCT04843852?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04843852 being conducted?
This trial has 1 study location across Maryland. 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 NCT04843852'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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