TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
This study is looking at whether the HEPLISAV-B vaccine, which normally prevents hepatitis B, is safe for people who already have chronic hepatitis B. Researchers want to see if HEPLISAV-B causes any side effects and how it affects the body's immune response in these patients. You could be eligible if you are over 18, have chronic hepatitis B (but not HIV, hepatitis C, or hepatitis D), and are currently taking medication (NUC) with a low viral load for at least 12 months. The study aims to enroll 10 participants. The study is currently unclear on its status.
- Study design
- This is an interventional study involving 10 participants with chronic hepatitis B. Participants will receive two doses of the HEPLISAV-B vaccine.
- What's involved
- You will receive two injections of HEPLISAV-B over 4 weeks. You will have 5 clinic visits and 3 phone calls over 14 months, and complete a diary for 7 days after each injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 12 months after your last vaccine dose to monitor for medically attended adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lydia Tang, MBChB · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
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What this trial measures
- Safety and reactogenicity of the Hepatitis B Virus Surface Antigen, Recombinant (HEPLISAV-B; Dynavax Technologies Corporation) Vaccine in patients with chronic hepatitis BBaseline to 7 days following each vaccine dose
Number of local and systemic solicited adverse events
- Occurence of unsolicited adverse eventsfrom dose 1 to 28 days following each vaccine dose
Number of unsolicited adverse events
- Medically Attended Adverse EventsFrom first vaccine to 12 months after last vaccine on study.
Number of Medically Attended Adverse Events (MAAEs)