title: Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine.
abstract: Adults 40 years of age and older have been shown to be hypo-responsive immunologically to the currently available hepatitis B virus (HBV) vaccines. Three intramuscular doses of a Toll-like receptor 9 agonist, 1018 immunostimulatory sequence (1018 ISS) adjuvant, combined with recombinant hepatitis B surface antigen (HBsAg) demonstrated faster, superior, and more durable seroprotection than three doses of a licensed comparator HBV vaccine (Engerix-B(®)). This investigational vaccine, HBsAg-1018 ISS, was well tolerated with a safety profile similar to the comparator vaccine. These results suggest that HBsAg-1018 may be more effective in this hypo-responsive population.
authors.affiliation: Out-Patient Department, Philippine General Hospital, Manila, Philippines.
authors.forename: Benjamin P
authors.initials: BP
authors.lastname: Sablan
authors.forename: Dong Joon
authors.initials: DJ
authors.lastname: Kim
authors.forename: Nina G
authors.initials: NG
authors.lastname: Barzaga
authors.forename: Wan Cheng
authors.initials: WC
authors.lastname: Chow
authors.forename: Mong
authors.initials: M
authors.lastname: Cho
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
authors.forename: Seong Gyu
authors.initials: SG
authors.lastname: Hwang
authors.forename: Ji Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: Hamid
authors.initials: H
authors.lastname: Namini
authors.forename: William L
authors.initials: WL
authors.lastname: Heyward
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood / Q000276:immunology; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D006514:Hepatitis B Surface Antigens / Q000235:genetics / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D056724:Immunity, Humoral; D008297:Male; D008875:Middle Aged; D009838:Oligodeoxyribonucleotides / Q000235:genetics / Q000276:immunology; D010919:Placebos; D051217:Toll-Like Receptor 9 / Q000819:agonists / Q000235:genetics / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D009838:Oligodeoxyribonucleotides; D010919:Placebos; D051217:Toll-Like Receptor 9; C489630:1018 oligonucleotide