HEPATITIS-B VACCINE CONTAINING SURFACE-ANTIGEN AND SELECTED PRES1 ANDPRES2 SEQUENCES .1. SAFETY AND IMMUNOGENICITY IN YOUNG, HEALTHY-ADULTS

The safety and immunogenicity of a yeast-derived recombinant hepatitis B virus (HBV) vaccine containing surface antigen (S) and selected pre S1 and preS2 sequences (S-L) were compared with those of a vaccine pr epared with S alone (Engerix(TM)-B). S-L consisted of composite parti cles containing S and L at a ratio of 70/30. L* encompassed amino aci d residues 12-52 of preS1 residues 133-145 of preS2, and the entire S domain. A total of 100 healthy, HBV-seronegative, young adults were ra ndomized to receive 20 mu g/dose of either S-L or Engerix(TM)-B under double-blind conditions according to a 0-, 1-, 2-, 12-month schedule. In vivo humoral and in vitro lymphoproliferative responses to S and p reS regions were monitored. Addition of the selected preS sequences to S did not enhance the in vivo humoral anti-HBs response but improved the in vitro stimulating capacity of the antigen (L) in S-L* primed s ubjects. (C) 1997 Elsevier Science Ltd.