TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B

NCT04843852 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HP-00115083
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Hepatitis B; Chronic Hepatitis B

Keywords

hepatitis B; Toll-like receptor; vaccine; hepatitis B surface antibody; HBsAb; anti-HBsAg; hepatitis B surface antigen; HBsAg; TLR9; CpG

Outcome Measures

Primary Outcomes (3)

• Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B

  Number of local and systemic solicited adverse events

  Baseline to 7 days following each vaccine dose

• Occurence of unsolicited adverse events

  Number of unsolicited adverse events

  from dose 1 to 28 days following each vaccine dose

• Medically Attended Adverse Events

  Number of Medically Attended Adverse Events (MAAEs)

  From first vaccine to 12 months after last vaccine on study.

Other Outcomes (3)

• Change in hepatitis B surface antigen levels

  Day 0 to week 28

• Anti-HBsAg Seroconversion

  Day 0 through 12 months post vaccination

• Changes in immunologic and virologic responses throughout study

  baseline to week 28

Study Arms (1)

Intervention

EXPERIMENTAL

HEPLISAV-B is available in pre-filled, single-dose 0.5 mL vials. Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant. HEPLISAV-B is administered as an intramuscular injection in the deltoid region. Study subjects will receive a total of 2 injections, each administered at least 4 weeks apart - the same dosing schedule recommended for hepatitis B prevention. Once enrolled, participants will have study visits on days 0 (first injection), and weeks 2, 4 (second injection), 8, and 28. They will also have phone follow ups on day 7 and week 5 (7 days after each injection) and week 56 (end of study).

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

Interventions

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

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Hepatitis B, Chronic

Interventions

Hepatitis B Vaccines; Heplisav-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Lydia Tang, MBChB

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Tang, MBChB

CONTACT

(410) 706-6567; LydiaTang@IHV.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 14, 2021
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)