A hepatitis B vaccine formulated with a novel adjuvant system

Although more than 95% of the vaccinated population responds to the current ly licensed vaccines against hepatitis B, some groups were found to be low responders. Lipid A as adjuvant, through its ability to activate macrophage s, 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: on e received the SBAS4 hepatitis B vaccine, the second Engerix-B(TM) and the third a hepatitis B vaccine with an alternative formulation on alum. Vaccin ations were at 0 and 6 months. The vaccine was well tolerated. At month 7 a ll vaccinees were protected but with significant differences in GMTs betwee n groups: 13,271 mIU/ml for the SBAS4 group versus 1203 and 1823 mIU/ml. He nce the hepatitis B vaccine with the new adjuvant system is more immunogeni c compared to the other vaccines containing the same antigen and could be s uitable for a two dose schedule. (C) 2000 Elsevier Science Ltd. All rights reserved.