AS04

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Template:Short description Adjuvant System 04 or AS04 is a trade name for a combination of adjuvants used in various vaccine products by GlaxoSmithKline,[1] in particular the Fendrix[2] hepatitis B vaccine and Cervarix[3] human papillomavirus (HPV) vaccine. It consists of aluminium hydroxide and monophosphoryl lipid A (MPL). It is the successor of AS03, a squalene based adjuvant used in H1N1/09 and H5N1 influenza vaccines.[4][5][6][7]

Efficacy and safety

HPV vaccines

Studies on an AS04-adjuvanted HPV-16/18 vaccine showed a high and sustained immune response to HPV antigens after injection, including in patients receiving subsequent doses.[8][9][10] Immune response was enhanced by the MPL component which triggered local NF-kB and cytokine production, leading to increased activation of antigen-presenting cells.[11] Immune response duration was extended by the aluminium hydroxide component. The HPV-16/18 AS04-adjuvanted vaccine showed enhanced efficacy compared to an aluminium salt-adjuvanted formulation, with a higher level of antibodies subsequently detected in the body.[12]

Long-term studies appear to show an adequate efficacy and safety profile.[13][14]

Hepatitis B vaccines

AS04-adjuvanted HBV vaccines may be relevant for patients that are non-responsive to other HBV vaccines,[15] including those with immunodeficiency.[16][17][18][19][20][21]

See also

References

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