TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response

TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B (NCT04843852) is a Phase 1 interventional studying Hepatitis B and Chronic Hepatitis B, sponsored by University of Maryland, Baltimore. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Hepatitis B, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: In order to participate in this study, an individual must meet all the following criteria: 1. \>18 years old 2. Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections 3. Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months 4. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures. 5. 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. Who Should NOT Join This Trial: A participant will be ineligible to participate on this study if any of the following criteria are met: 1. Pregnancy or breast feeding. 2. 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. 3. 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). 4. Administration of any blood products within 3 months prior to randomization. 5. Participation in a study with an investigational study product or device within 30 days of randomization. 6. Has allergies to any hepatitis B and/or yeast-based vaccines. 7. Subjects meeting any of the following laboratory parameters at screening: 1. ALT greater than 3 times the upper limit of normal 2. Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: In order to participate in this study, an individual must meet all the following criteria: 1. \>18 years old 2. Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections 3. Currently receiving NUC with HBV VL \<100 IU/ml for ≥ 12 months 4. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures. 5. 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: 1. Pregnancy or breast feeding. 2. 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. 3. 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). 4. Administration of any blood products within 3 months prior to randomization. 5. Participation in a study with an investigational study product or device within 30 days of randomization. 6. Has allergies to any hepatitis B and/or yeast-based vaccines. 7. Subjects meeting any of the following laboratory parameters at screening: 1. ALT greater than 3 times the upper limit of normal 2. Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal 8. 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. 9. Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.

Treatments Being Tested

DRUG

Hepatitis B Vaccine Recombinant, Adjuvanted Intramuscular Solution [HEPLISAV-B]

one 0.5ml intramuscular injection on day 0 and week 4.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04843852), the sponsor (University of Maryland, Baltimore), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04843852 clinical trial studying?

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 tota… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04843852?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04843852?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04843852. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04843852. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.