Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
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.
⁃ 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.