title: Review of hepatitis B surface antigen-1018 ISS adjuvant-containing vaccine safety and efficacy.
abstract: Existing hepatitis B virus (HBV) vaccines produce seroprotective titers in > 90% of healthy adult recipients following 3 doses administered over 6 months. The durability of this response is variable. Vaccine efficacy is greatly diminished in immune compromised patients. Given the high worldwide prevalence and burden of disease produced by chronic HBV infection, vaccines capable of producing high rates of durable seroprotective HBV surface antibody titers are required. Immunostimulatory sequences (ISS) containing repeating sequences of cytosine phosphoguanosine (CpG) dinucleotide motifs have emerged as useful tools for modulating immune responses. Dynavax Technologies produced a synthetic oligodexynucleotide (ODN) containing these motifs, resulting in an unmethylated cytosine and phosphoguanosine ODN called 1018 ISS. Dynavax's hepatitis B virus vaccine HEPLISAV is comprised of 1018 ISS mixed with recombinant hepatitis B surface antigen. Clinical trials, to date, have shown that HEPLISAV produces rapid, high titer, sustained seroprotection in healthy adults and vaccine hyporesponsive populations. Although additional supporting data are required, this represents a promising strategy to facilitate worldwide HBV prevention efforts.
authors.affiliation: University of Ottawa, The Ottawa Hospital, Division of Infectious Diseases, Room G12-501 Smyth Road, Ottawa, K1H 8L6, ON, Canada.
authors.forename: Mazin
authors.initials: M
authors.lastname: Barry
authors.forename: Curtis
authors.initials: C
authors.lastname: Cooper
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006801:Humans; D007167:Immunotherapy; D009369:Neoplasms / Q000188:drug therapy / Q000276:immunology; D009838:Oligodeoxyribonucleotides / Q000627:therapeutic use*
chemical_list: D000276:Adjuvants, Immunologic; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D009838:Oligodeoxyribonucleotides; C489630:1018 oligonucleotide