Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children.

We tested the safety and immunogenicity of the new recombinant hepatitis B virus (HBV) vaccine produced via expression of the Pre-S1, Pre-S2 and S protein components of the hepatitis B surface antigen (HBsAg). A reduced dose (2.5 micrograms) of the vaccine (Bio-Hep-B) was tested in children aged 4-9 years and was compared to a 10 microgram dose of a licensed vaccine (Engerix-B) in a randomized manner.