Engerix-B a Hepatitis B Vaccine (Recombinant) is a noninfectious recombinant DNA hepatitis B vaccine.
It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus.
The surface antigen expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminum hydroxide. The procedures used to manufacture ENGERIX-B result in a product that contains no more than 5% yeast protein. No substances of human origin are used in its manufacture.
Engerix-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.
Engerix-B is administered as an intramuscular injection.
Primary immunization for infants (born of hepatitis B surface antigen [HBsAg]-negative or HBsAg-positive mothers), children (birth through 10 years), and adolescents (aged 11 through 19 years) consist of a series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.
Primary immunization for persons aged 20 years and older consists of a series of 3 doses (1 mL each) given on a 0-, 1-, and 6-month schedule.