Drug intelligence / Profile preview

hepatitis B surface antigen + monophosphoryl lipid A

Development stage
Unknown
Lead developer
GSK
Modality
Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Hepatitis B surface antigen + monophosphoryl lipid A is an adjuvanted recombinant subunit vaccine designed for the prevention of hepatitis B virus (HBV) infection. It consists of the recombinant hepatitis B surface antigen (HBsAg) combined with the AS04 adjuvant system, which contains 3-O-desacyl-4'-monophosphoryl lipid A (MPL) adsorbed onto aluminum phosphate. MPL is a detoxified derivative of lipid A from *Salmonella minnesota* and acts as a Toll-like receptor 4 (TLR4) agonist, stimulating the innate immune response and enhancing the production of protective anti-HBs antibodies. This formulation is specifically indicated for individuals who are at high risk of infection and often show a poor response to conventional vaccines, such as patients with renal insufficiency (including pre-hemodialysis and hemodialysis patients) and other immunocompromised populations. Clinical studies, including Phase 3 trials in Spain, have also demonstrated its efficacy in inducing protective antibody titers in healthcare workers who previously failed to respond to standard HBV vaccination.

Brand names
Fendrix
Other names
adjuvanted hepatitis B vaccineHBsAg-MPL vaccinehepatitis B vaccine (adjuvanted)
02

Targets

Hepatitis B surface antigen-specific T-cell receptorTLR4 (Toll-like receptor 4)

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