Adjuvant System 04 or AS04 is a trade name for a combination of

adjuvants In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analge ...

used in various vaccine products by

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

, 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 ...

and

Cervarix Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV). Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced ...

human papillomavirus (HPV) vaccine. It consists of

aluminium hydroxide Aluminium hydroxide, , is found as the mineral gibbsite (also known as hydrargillite) and its three much rarer polymorphs: bayerite, doyleite, and nordstrandite. Aluminium hydroxide is amphoteric, i.e., it has both basic and acidic propert ...

and monophosphoryl lipid A (MPL). 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 Arepanri ...

, a

squalene Squalene is an organic compound. It is a triterpene 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 used in H1N1/09 and

H5N1 Influenza A virus subtype H5N1 (A/H5N1) is a subtype of the influenza A virus, which causes the disease avian influenza (often referred to as "bird flu"). It is enzootic (maintained in the population) in many bird populations, and also panzoo ...

influenza Influenza, commonly known as the flu, is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These sympto ...

vaccines A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an ag ...

Efficacy and safety

HPV vaccines

Studies on an AS04-adjuvanted HPV-16/18 vaccine showed a high and sustained

immune response An immune response is a physiological reaction which occurs within an organism in the context of inflammation for the purpose of defending against exogenous factors. These include a wide variety of different toxins, viruses, intra- and extracellula ...

to HPV

antigens In immunology, an antigen (Ag) is a molecule, moiety, foreign particulate matter, or an allergen, such as pollen, that can bind to a specific antibody or T-cell receptor. The presence of antigens in the body may trigger an immune response. An ...

after injection, including in patients receiving subsequent doses. Immune response was enhanced by the MPL component which triggered local NF-kB and

cytokine Cytokines () are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are produced by a broad range of cells, including immune cells like macrophages, B cell, B lymphocytes, T cell, T lymphocytes ...

production, leading to increased activation of

antigen-presenting cells An antigen-presenting cell (APC) or accessory cell is a cell that displays an antigen bound by major histocompatibility complex (MHC) proteins on its surface; this process is known as antigen presentation. T cells may recognize these complexes u ...

. Immune response duration was extended by the

component. The HPV-16/18 AS04-adjuvanted vaccine showed enhanced efficacy compared to an aluminium salt-adjuvanted formulation, with a higher level of

antibodies An antibody (Ab) or immunoglobulin (Ig) is a large, Y-shaped protein belonging to the immunoglobulin superfamily which is used by the immune system to identify and neutralize antigens such as bacteria and viruses, including those that caus ...

subsequently detected in the body. Long-term studies appear to show an adequate efficacy and safety profile.

Hepatitis B vaccines

AS04-adjuvanted HBV vaccines may be relevant for patients that are non-responsive to other HBV vaccines, including those with

immunodeficiency Immunodeficiency, also known as immunocompromise, is a state in which the immune system's ability to fight infectious diseases and cancer is compromised or entirely absent. Most cases are acquired ("secondary") due to extrinsic factors that aff ...

References

{{Reflist Adjuvants

Efficacy and safety

HPV vaccines

Hepatitis B vaccines

See also

References