Jump to content

AS04

Edit links
From Wikipedia, the free encyclopedia

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

[edit]

HPV vaccines

[edit]

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

[edit]

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

[edit]

References

[edit]
  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.{{cite journal}}: CS1 maint: numeric names: authors list (link)
  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. hdl:1765/119465. 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.


Stub icon

This biochemistry article is a stub. You can help Wikipedia by expanding it.

Retrieved from "https://en.wikipedia.org/w/index.php?title=AS04&oldid=1257597998"
pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy