Phase 1 Hepatitis B Trial, Recruiting NCT04843852 Sponsor: University of Maryland, Baltimore Condition: Hepatitis B
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Phase 1 Hepatitis B Trial, Recruiting

NCT04843852
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are over 18 years old
  • People who have been diagnosed with chronic hepatitis B infection (meaning a positive hepatitis B test result for at least 6 months), without also having HIV, hepatitis C, or hepatitis D
  • People who have been taking antiviral medication for hepatitis B and whose hepatitis B virus levels in the blood have been very low (below 100 IU/ml) for at least 12 months
  • People who are able and willing to attend all scheduled visits, follow the vaccination plan, and complete all required tests and study procedures
  • People who a doctor has determined to be in good general health based on their medical history and a physical examination

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People who have taken strong immune-suppressing or immune-modifying medicines for more than 14 days in total within the past 6 months (including certain steroid medicines at higher doses), or who have received a specific type of immune-suppressing treatment called anti-CD20 therapy within the past 12 months
  • People who have recently received certain vaccines or who plan to receive non-study vaccines close to the time of study vaccinations (specific timeframes apply — confirm with trial site)
  • People who have received blood products such as transfusions within the 3 months before joining the trial
  • People who have taken part in another clinical trial involving an experimental treatment or device within the past 30 days
  • People who have a known allergy to hepatitis B vaccines or yeast-based vaccines
  • People whose blood test results at the time of screening show certain signs of liver stress, specifically liver enzyme levels (ALT) more than 3 times the normal upper limit, or elevated bilirubin levels above a certain threshold
  • People who are acutely unwell or have a fever (38.0°C/100.4°F or above) within 72 hours before or at the time of receiving the study vaccine
  • People who have any ongoing, sudden, or unstable health conditions that the investigating doctor considers a reason not to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lydia Tang, MBChB, University of Maryland, Baltimore

Phone: (410) 706-6567

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
16 October 2025
Est. completion
31 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis B; Occurence of unsolicited adverse events; Medically Attended Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov