A hepatitis B vaccine formulated with a novel adjuvant system

Vaccine. 2000 Apr 14;18(20):2095-101. doi: 10.1016/s0264-410x(99)00566-6.


Although more than 95% of the vaccinated population responds to the currently licensed vaccines against hepatitis B, some groups were found to be low responders. Lipid A as adjuvant, through its ability to activate macrophages, might improve humoral as well as cellular immune response. Therefore we evaluated the profile of a hepatitis B vaccine with the new adjuvant system SBAS4. 150 young adults were enrolled and randomized into three groups: one received the SBAS4 hepatitis B vaccine, the second Engerix-B(TM) and the third a hepatitis B vaccine with an alternative formulation on alum. Vaccinations were at 0 and 6 months. The vaccine was well tolerated. At month 7 all vaccinees were protected but with significant differences in GMTs between groups: 13,271 mIU/ml for the SBAS4 group versus 1203 and 1823 mIU/ml. Hence the hepatitis B vaccine with the new adjuvant system is more immunogenic compared to the other vaccines containing the same antigen and could be suitable for a two dose schedule.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic* / adverse effects
  • Adolescent
  • Adult
  • Alum Compounds* / adverse effects
  • Double-Blind Method
  • Edema / etiology
  • Fatigue / etiology
  • Female
  • Follow-Up Studies
  • Headache / etiology
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B Antibodies / blood
  • Hepatitis B Vaccines / adverse effects
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunity, Cellular
  • Immunization, Secondary / adverse effects
  • Lipid A* / adverse effects
  • Lymphocyte Activation
  • Male
  • Pain / etiology
  • Safety
  • Seroepidemiologic Studies
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology


  • Adjuvants, Immunologic
  • Alum Compounds
  • Engerix-B
  • Hepatitis B Antibodies
  • Hepatitis B Vaccines
  • Lipid A
  • SBAS4 adjuvant system
  • Vaccines, Synthetic
  • aluminum sulfate