Adjuvant System 04 or AS04 is a trade name for combination of adjuvants used in various vaccine products by

GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British Multinational corporation, multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a Mergers and acquisitions, merger of Gl ...

, in particular the Fendrix

hepatitis B vaccine Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and ...

. It is also one of the ingredients of the human papillomavirus vaccine (HPV). Studies of AS04-adjuvanted HPV vaccine showed high and justified immune response against to HPV antigens. Furthermore, patients who took HPV-16/18 AS04-adjuvanted vaccine previously showed strong rapid responses upon receiving subsequent doses. It consists of aluminum hydroxide and monophosphoryl lipid A (MPL). Furthermore, it is the successor of

AS03 AS03 (for "Adjuvant System 03") is the trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline (GSK). It is used, for example, in GSK's A/H1N1 pandemic flu vaccine Pandemrix. It is also in Arepan ...

which is a

squalene Squalene is an organic compound. It is a triterpenoid with the formula C30H50. It is a colourless oil, although impure samples appear yellow. It was originally obtained from shark liver oil (hence its name, as '' Squalus'' is a genus of sharks). ...

based adjuvant approved for pandemic vaccine by the EMA. The heightened

immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could ...

was caused by the MPL component in AS04 which increased NF-kB and

cytokine Cytokines are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are peptides and cannot cross the lipid bilayer of cells to enter the cytoplasm. Cytokines have been shown to be involved in a ...

production. The aluminum hydroxide component in AS04 made the response last for a longer period of time. This is the reason why the HPV-16/18 AS04-adjuvanted vaccine was shown to be more efficient compared to an aluminum salt-adjuvanted formulation with a higher level of antibodies found in the body.

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