NCT04843852 · University of Maryland, Baltimore
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
(BOOST-9)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]
one 0.5ml intramuscular injection on day 0 and week 4.
Primary outcome measures
Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B
Time frame: Baseline to 7 days following each vaccine dose
Number of local and systemic solicited adverse events
Occurence of unsolicited adverse events
Time frame: from dose 1 to 28 days following each vaccine dose
Number of unsolicited adverse events
Medically Attended Adverse Events
Time frame: From first vaccine to 12 months after last vaccine on study.
Number of Medically Attended Adverse Events (MAAEs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- In order to participate in this study, an individual must meet all the following criteria:
- \>18 years old
- Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections
- Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Determined by medical history, targeted physical examination, and clinical judgement of the investigator to be in good health. CHB infection is defined as any individual with documentation of a positive HBsAg and/or detectable HBV DNA test for at least 6 months.
Exclusion criteria
- A participant will be ineligible to participate on this study if any of the following criteria are met:
- Pregnancy or breast feeding.
- Received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to Screening (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Received anti-CD20 immunosuppressant within 12 months of screening. Topical tacrolimus is allowed if not used within 14 days prior to Day 1.
- Received or plans to receive live virus vaccines within 4 weeks, and inactivated vaccine within 2 weeks prior to randomization; or plans to receive a non-study vaccine within 28 days after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).
- Administration of any blood products within 3 months prior to randomization.
- Participation in a study with an investigational study product or device within 30 days of randomization.
- Has allergies to any hepatitis B and/or yeast-based vaccines.
- Subjects meeting any of the following laboratory parameters at screening:
- ALT greater than 3 times the upper limit of normal
- Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal
- Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as ≥ 38.0°C/100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.
Where
- Baltimore, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations