Actively Recruiting
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Led by University of Maryland, Baltimore · Updated on 2025-10-20
10
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosed with chronic hepatitis B infection without co-infections of HIV, hepatitis C, or hepatitis D
- Receiving nucleos(t)ide analogue therapy with hepatitis B viral load below 100 IU/ml for at least 12 months
- Willing and able to attend all scheduled visits, vaccinations, laboratory tests, and study procedures
- Considered in good health based on medical history, physical exam, and investigator's judgment
- Chronic hepatitis B infection defined by positive HBsAg and/or detectable HBV DNA for at least 6 months
You will not qualify if you...
- Pregnant or breastfeeding
- Use of systemic immunosuppressants or immune-modifying drugs for more than 14 days within 6 months prior to screening (including corticosteroids ≥ 20 mg/day prednisone equivalent)
- Received anti-CD20 immunosuppressant within 12 months prior to screening
- Received or plans to receive live virus vaccines within 4 weeks or inactivated vaccines within 2 weeks prior to randomization; plans to receive non-study vaccines within 28 days after any study vaccine dose (except seasonal influenza vaccine within 14 days)
- Received blood products within 3 months prior to randomization
- Participated in a study with investigational product or device within 30 days prior to randomization
- Allergic to hepatitis B or yeast-based vaccines
- ALT greater than 3 times upper limit of normal
- Elevated total bilirubin with direct bilirubin greater than 2 times upper limit of normal
- Acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) within 72 hours before vaccine dosing
- Any chronic, acute, or unstable conditions that contraindicate study participation as determined by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
L
Lydia Tang, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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