Fendrix (GSK)

Fendrix is a recombinant protein subunit vaccine developed by GSK for active immunization against hepatitis B virus (HBV). It is specifically designed for patients with renal insufficiency, including those undergoing hemodialysis, who often exhibit a suboptimal immune response to standard hepatitis B vaccines. The formulation contains 20 µg of recombinant hepatitis B surface antigen (HBsAg) produced in *Saccharomyces cerevisiae*. A defining feature of Fendrix is the use of the AS04 adjuvant system, which combines 50 µg of 3-O-desacyl-4'-monophosphoryl lipid A (MPL), a detoxified derivative of bacterial lipopolysaccharide that acts as a TLR4 agonist, with aluminum phosphate. This combination is intended to enhance the magnitude and duration of the immune response by stimulating both innate and adaptive pathways. In clinical trials, 'Formulation B' referred to the 20 µg HBsAg dose adjuvanted with AS04, which was subsequently marketed as Fendrix.

Brand names

Fendrix

Other names

HBV-MPL vaccine formulation B-GlaxoSmithKline-hepatitis BHepatitis B (recombinant) vaccine (adjuvanted, adsorbed)Hepatitis B vaccine (adjuvanted)