HEPLISAV-B (TLR‑9 adjuvanted) vaccine for adults with chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial enrolls ten adults with chronic hepatitis B who have been virally suppressed on nucleos(t)ide analogue (NUC) therapy. Participants receive two 0.5 mL intramuscular doses of HEPLISAV-B (a CpG/TLR‑9–adjuvanted vaccine) on day 0 and week 4, with clinic visits and blood draws at specified intervals and short-term symptom diaries after each injection. The study’s primary focus is safety and characterization of immune-cell responses following vaccination. Follow-up includes five clinic visits over 28 weeks and additional phone checks out to week 56.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Lydia Tang, MBChB — University of Maryland, Baltimore
• Study coordinator: Lydia Tang, MBChB
• Email: LydiaTang@IHV.umaryland.edu
• Phone: (410) 706-6567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.