Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine

Vaccine. 2012 Mar 30;30(16):2689-96. doi: 10.1016/j.vaccine.2012.02.001. Epub 2012 Feb 14.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic
  • Adult
  • Aged
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control*
  • Hepatitis B / virology
  • Hepatitis B Surface Antigens / genetics
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B Vaccines / adverse effects
  • Hepatitis B Vaccines / genetics
  • Hepatitis B Vaccines / immunology*
  • Hepatitis B virus / immunology*
  • Humans
  • Immunity, Humoral
  • Male
  • Middle Aged
  • Oligodeoxyribonucleotides / genetics
  • Oligodeoxyribonucleotides / immunology
  • Placebos
  • Toll-Like Receptor 9 / agonists
  • Toll-Like Receptor 9 / genetics
  • Toll-Like Receptor 9 / immunology

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Oligodeoxyribonucleotides
  • Placebos
  • Toll-Like Receptor 9
  • 1018 oligonucleotide