AS04

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]

Further reading

See also

References
  1. "Vaccine Adjuvant System Technology Background Information" (PDF). Archived from the original (PDF) on 2009-01-05.
  2. "Products | GSKpro". Archived from the original on 2013-03-04.
  3. "Products | GSKpro". Archived from the original on 2009-05-29.
  4. Ellis, Ronald W.; Rappuoli, Rino; Ahmed, Sohail (2013). "Technologies for making new vaccines". In Plotkin, Stanley A.; Orenstein, Walter A.; Offit, Paul A. (eds.). Vaccines (Sixth ed.). W.B. Saunders. pp. 1182–1199. doi:10.1016/B978-1-4557-0090-5.00013-6. ISBN 9781455700905.
  5. Garçon, Nathalie; Van Mechelen, Marcelle; Wettendorff, Martine (2006). "Development and evaluation of AS04, a novel and improved adjuvant system containing MPL and aluminum salt". Immunopotentiators in Modern Vaccines. pp. 161–177. doi:10.1016/B978-012088403-2/50011-3. ISBN 9780120884032.
  6. Laupèze, Béatrice; Hervé, Caroline; Di Pasquale, Alberta; Tavares Da Silva, Fernanda (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. 37 (38): 5670–5680. doi:10.1016/j.vaccine.2019.07.098. PMID 31420171. S2CID 201042219.
  7. Garçon, N.; Di Pasquale, A. (2016). "From discovery to licensure, the Adjuvant System story". Human Vaccines & Immunotherapeutics. 13 (1): 19–33. doi:10.1080/21645515.2016.1225635. PMC 5287309. PMID 27636098.
  8. Garçon, N.; Morel, S.; Didierlaurent, A.; Descamps, D.; Wettendorff, M.; Van Mechelen, M. (2011). "Development of an AS04-adjuvanted HPV vaccine with the adjuvant system approach". BioDrugs. 25 (4): 217–226. doi:10.2165/11591760-000000000-00000. PMID 21815697. S2CID 25608550.
  9. Keam, Susan J.; Harper, Diane M. (2008). "Human Papillomavirus Types 16 and 18 Vaccine (Recombinant, AS04 Adjuvanted, Adsorbed (Cervarix))". Drugs. 68 (3): 359–372. doi:10.2165/00003495-200868030-00007. PMID 18257611. S2CID 39629514.
  10. Schwarz, Tino F.; Spaczynski, Marek; Schneider, Achim; Wysocki, Jacek; Galaj, Andrzej; Perona, Pamela; Poncelet, Sylviane; Zahaf, Toufik; Hardt, Karin; Descamps, Dominique; Dubin, Gary; HPV Study Group for Adult Women (2009). "Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15–55 years". Vaccine. 27 (4): 581–587. doi:10.1016/j.vaccine.2008.10.088. PMID 19022320.
  11. Didierlaurent, Arnaud M.; Morel, Sandra; Lockman, Laurence; Giannini, Sandra L.; Bisteau, Michel; Carlsen, Harald; Kielland, Anders; Vosters, Olivier; Vanderheyde, Nathalie; Schiavetti, Francesca; Larocque, Daniel (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. 183 (10): 6186–6197. doi:10.4049/jimmunol.0901474. ISSN 0022-1767. PMID 19864596.
  12. Giannini, S.; Hanon, E.; Moris, P.; Vanmechelen, M.; Morel, S.; Dessy, F.; Fourneau, M.; Colau, B.; Suzich, J.; Losonksy, G.; Martin, M. T.; Dubin, G.; Wettendorff, M. A. (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. 24 (33–34): 5937–5949. doi:10.1016/j.vaccine.2006.06.005. PMID 16828940.
  13. Bi, Dan; Apter, Dan; Eriksson, Tiina; Hokkanen, Mari; Zima, Julia; Damaso, Silvia; Soila, Maaria; Dubin, Gary; Lehtinen, Matti; Struyf, Frank (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. 16 (6): 1392–1403. doi:10.1080/21645515.2019.1692557. PMC 7482795. PMID 31829767. S2CID 209341449.
  14. GlaxoSmithKline Vaccine HPV-007 Study Group; et al. (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. 374 (9706): 1975–1985. doi:10.1016/S0140-6736(09)61567-1. PMID 19962185. S2CID 30776042.
  15. Tejada-Pérez, Juan José; Vázquez-Vicente, Juan José; Herrera-Burgos, María Renée; Martín-Martín, Francisco Gabriel; Parrón-Carreño, Tesifón; Alarcón-Rodríguez, Raquel (2021). "Fendrix® Vaccine Effectiveness in Healthcare Workers Who Are Non-Responsive to Engerix B® Vaccination". Vaccines. 9 (3): 279. doi:10.3390/vaccines9030279. PMC 8003400. PMID 33808589.
  16. Machiels, Julian D.; Braam, Esmée E.; Van Bentum, Petra; Van Vugt, Michèle; De Vries-Sluijs, Theodora E.M.S.; Schouten, Ineke W.E.M.; Bierman, Wouter F.W.; Gisolf, Elisabeth H. (2019). "Vaccination with Fendrix of prior nonresponding patients with HIV has a high success rate". AIDS. 33 (3): 503–507. doi:10.1097/QAD.0000000000002085. PMID 30702518. S2CID 73414009.
  17. Horta, D.; Forné, M.; Agustí, A.; Raga, A.; Martín-Cardona, A.; Hernández-Soto, J. M.; Ruiz-Ramírez, P.; Esteve-Comas, M. (2022). "Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients with Chronic Liver Disease in Clinical Practice". Vaccines. 10 (8): 1323. doi:10.3390/vaccines10081323. PMC 9416157. PMID 36016211.
  18. Chiew Tong, Norella Kong; Beran, Jiri; Kee, Swee Ann; Miguel, Jose Luisa; Sannchez, Carmen; Bayas, Jose Maria; Vilella, A.; De Juanes, J.R.; Arrazola, P.; Calbo-Torrecillas, Francisco; De Novales, Eduardo Lapez; Hamtiaux, Virginie; Lievens, Marc; Stoffel, Michel (2005). "Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients". Kidney International. 68 (5): 2298–2303. doi:10.1111/j.1523-1755.2005.00689.x. PMID 16221232. S2CID 25535605.
  19. Fabrizi, Fabrizio; Cerutti, Roberta; Nardelli, Luca; Tripodi, Federica; Messa, Piergiorgio (2020). "HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population". Clinics and Research in Hepatology and Gastroenterology. 44 (1): 49–56. doi:10.1016/j.clinre.2019.06.010. hdl:2434/672871. PMID 31327620. S2CID 198135022.
  20. Fabrizi, Fabrizio; Cerutti, Roberta; Garcia-Agudo, Rebeca; Bellincioni, Cecilia; Porata, Giulia; Frontini, Giulia; Aoufi-Rabih, Sami; Messa, Piergiorgio (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. 44 (6): 905–912. doi:10.1016/j.clinre.2020.01.010. PMID 32144074. S2CID 212622741.
  21. Fabrizi, Fabrizio; Tarantino, Antonio; Castelnovo, Claudia; Martin, Paul; Messa, Piergiorgio (2015). "Recombinant Hepatitis B Vaccine Adjuvanted with AS04 in Dialysis Patients: A Prospective Cohort Study". Kidney and Blood Pressure Research. 40 (6): 584–592. doi:10.1159/000368534. hdl:2434/588627. PMID 26566033. S2CID 207555753.


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