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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.
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