Safety and immunogenicity of a hepatitis B vaccine formulated with a novel adjuvant system

A formulation of recombinant hepatitis B surface antigen (HBsAg) combined with a novel adjuvant system, SBAS4-a combination of aluminium salt and monophosphoryl lipid A (MPL), was assessed in 27 healthy adult volunteers with a commercial vaccine (Engerix-B(R)) as control, After three doses (0, 1, 6 months schedule), reactogenicity profiles were similar: Local reactions were essentially mild, the most frequent being soreness at the injection site. Seroprotection was achieved after two doses in all subjects given the candidate vaccine all Engerix-B(R) vaccinees being seroprotected after the third close. After the second and third doses, higher anti-HBs Geometric Mean Titres (GMTs) were observed in the group which received the formulation with the novel adjuvant system, and cellular immunity, measured as HBsAg-specific lymphoproliferation was stronger than with Engerix-B(R). These results indicate that the new formulation is safe, well-tolerated and immunogenic and may promote more rapid protection against hepatitis B infection. (C) 1998 Elsevier Science Ltd, All rights reserved.