Hepatitis B Clinical Trial
Official title:
Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
Unmethylated cystine-guanosine dinucleotide (CpG) motifs are pathogen-associated molecular patterns (PAMPs) associated with bacterial and viral-derived DNA that activate the innate and humoral immunity via toll-like receptor 9. This is a randomized controlled pilot study evaluating the clinical and immune correlates of a seroprotective immune response against a CpG-adjuvanted vaccine for hepatitis B.
This is an open-label, randomized, pilot study to assess the effect of CpG-adjuvanted vaccination among people with chronic hepatitis B. This study will evaluate the effect of CpG-adjuvanted vaccination on B-cells that produce anti-HBsAg antibody. The primary hypothesis is that TLR9 agonism with CpG-adjuvanted hepatitis B vaccine will increase the number of anti-HBsAg producing B-cells in people with chronic hepatitis B infection who are virally suppressed on nucleos(t)ide analogue (NUC) therapy. In this study, 40 people with chronic hepatitis B virally suppressed on NUC therapy will be randomized in a 1:1 fashion to receive an 0.5ml intramuscular injection of HEPLISAV-B vaccine - an FDA approved vaccine for preventing hepatitis B infection. Participants randomized to receive the vaccine will receive a total of 2 injections, at day 0 and week 4. Participants will be evaluated at days 7, 14, 28, 35, 56, 96, 393 for adverse events, with and blood sample collections on days 0, 14, 28, 56, 196. ;
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