AS04

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Combination of adjuvants

title: "AS04" type: doc version: 1 created: 2026-02-28 author: "Wikipedia contributors" status: active scope: public tags: ["adjuvants"] description: "Combination of adjuvants" topic_path: "general/adjuvants" source: "https://en.wikipedia.org/wiki/AS04" license: "CC BY-SA 4.0" wikipedia_page_id: 0 wikipedia_revision_id: 0

::summary Combination of adjuvants ::

Adjuvant System 04 or AS04 is a trade name for a combination of adjuvants used in various vaccine products by GlaxoSmithKline, in particular the Fendrix hepatitis B vaccine and Cervarix 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.

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. Immune response was enhanced by the MPL component which triggered local NF-kB and cytokine production, leading to increased activation of antigen-presenting cells. 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.

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.

References

References

  1. "Vaccine Adjuvant System Technology Background Information".
  2. "Products | GSKpro".
  3. "Products | GSKpro".
  4. (2013). "[[Plotkin's Vaccines". W.B. Saunders.
  5. (2006). "Immunopotentiators in Modern Vaccines".
  6. (2019). "Adjuvant Systems for vaccines: 13 years of post-licensure experience in diverse populations have progressed the way adjuvanted vaccine safety is investigated and understood". Vaccine.
  7. (2016). "From discovery to licensure, the Adjuvant System story". Human Vaccines & Immunotherapeutics.
  8. (2011). "Development of an AS04-adjuvanted HPV vaccine with the adjuvant system approach". BioDrugs.
  9. (2008). "Human Papillomavirus Types 16 and 18 Vaccine (Recombinant, AS04 Adjuvanted, Adsorbed (Cervarix))". Drugs.
  10. (2009). "Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15–55 years". Vaccine.
  11. (2009-11-15). "AS04, an Aluminum Salt- and TLR4 Agonist-Based Adjuvant System, Induces a Transient Localized Innate Immune Response Leading to Enhanced Adaptive Immunity". The Journal of Immunology.
  12. (2006). "Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/Aluminium salt combination (AS04) compared to aluminium salt only". Vaccine.
  13. (2020). "Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: End-of-study results from a community-randomized study up to 6.5 years". Human Vaccines & Immunotherapeutics.
  14. (2009). "Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: Analysis of a randomised placebo-controlled trial up to 6·4 years". The Lancet.
  15. (2021). "Fendrix® Vaccine Effectiveness in Healthcare Workers Who Are Non-Responsive to Engerix B® Vaccination". Vaccines.
  16. (2019). "Vaccination with Fendrix of prior nonresponding patients with HIV has a high success rate". AIDS.
  17. (2022). "Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients with Chronic Liver Disease in Clinical Practice". Vaccines.
  18. (2005). "Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients". Kidney International.
  19. (2020). "HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population". Clinics and Research in Hepatology and Gastroenterology.
  20. (2020). "Adjuvanted recombinant HBV vaccine (HBV-AS04) is effective over extended follow-up in dialysis population. An open-label non randomized trial". Clinics and Research in Hepatology and Gastroenterology.
  21. (2015). "Recombinant Hepatitis B Vaccine Adjuvanted with AS04 in Dialysis Patients: A Prospective Cohort Study". Kidney and Blood Pressure Research.

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adjuvants