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.
Ten people with chronic hepatitis B and virally suppressed on nucleos(t)ide analogue (NUC) therapy will receive a total of two 0.5ml intramuscular injections of HEPLISAV-B, a CpG-adjuvanted vaccine, the first injection on day 0, and the second injection on week 4. Participants will visit the clinic on day 0, and weeks 2, 4, 8, and 28. They will also have phone follow ups on day 7, and weeks 5 and 56. At each follow up, participants will be asked about any side effects. At each clinic visit blood samples will be collected. For 7 days after each HEPLISAV-B injection, participants will complete a diary to document any reactions to the injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
one 0.5ml intramuscular injection on day 0 and week 4.
Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGSafety 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
Time frame: Baseline to 7 days following each vaccine dose
Occurence of unsolicited adverse events
Number of unsolicited adverse events
Time frame: from dose 1 to 28 days following each vaccine dose
Medically Attended Adverse Events
Number of Medically Attended Adverse Events (MAAEs)
Time frame: From first vaccine to 12 months after last vaccine on study.
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