SAFETY AND IMMUNOGENICITY OF A HEPATITIS-B VACCINE FORMULATED WITH A NOVEL ADJUVANT SYSTEM

A formulation of recombinant hepatitis B surface antigen (HBsAg) combi ned with a novel adjuvant system, SBAS4-a combination of aluminium sal t and monophosphoryl lipid A (MPL), was assessed in 27 healthy adult v olunteers with a commercial vaccine (Engerix-B(R)) as control, After t hree doses (0, 1, 6 months schedule), reactogenicity profiles were sim ilar: Local reactions were essentially mild, the most frequent being s oreness at the injection site. Seroprotection was achieved after two d oses in all subjects given the candidate vaccine all Engerix-B(R) vacc inees being seroprotected after the third close. After the second and third doses, higher anti-HBs Geometric Mean Titres (GMTs) were observe d in the group which received the formulation with the novel adjuvant system, and cellular immunity, measured as HBsAg-specific lymphoprolif eration was stronger than with Engerix-B(R). These results indicate th at 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.