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Encyclopedia > Cervarix

Cervarix is a vaccine against certain types of the human papillomavirus (HPV) that cause cervical cancer. It received approval in May 2007 in Australia for women ages 10 to 45.[1]. If approved in the United States, will be marketed by GlaxoSmithKline. It is designed to prevent infection from HPV types 16 and 18, which currently cause about 70% of HPV-related cervical cancer cases. Type 16 has also been found to be associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.[2] Additionally, "substantial" protection against virus strains 45 and 31 were shown in clinical trials.[3] Cervarix is also formulated with AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period of time.[4] A vaccine is an antigenic preparation used to establish immunity to a disease. ... “HPV” redirects here. ... GlaxoSmithKline plc (LSE: GSK NYSE: GSK) is a British based pharmaceutical, biological, and healthcare company. ... Cervical cancer is a malignant cancer of the cervix. ... Proprietary indicates that a party, or proprietor, exercises private ownership, control or use over an item of property, usually to the exclusion of other parties. ... In medicine, adjuvants are agents which modify the effect of other agents while having few if any direct effects when given by themselves. ... A scanning electron microscope image of a single neutrophil (yellow), engulfing anthrax bacteria (orange). ...

Contents

Biotechnology

Cervarix is created using the L1 protein of the viral capsid. Recombinant activity in a baculovirus vector produces L1 protein spheres, which are very immunogenic. The viral proteins induce the formation of neutralizing antibodies. The vaccine contains no live virus and no DNA, so it cannot infect the patient. The vaccine was developed, in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the U.S. National Cancer Institute [5] . A capsid is the outer shell of a virus. ... This article is about biological infectious particles. ... Georgetown University is an elite private research university located in Georgetown, Washington, D.C., United States. ... The University of Rochester (UR) is a private, coeducational and nonsectarian research university located in Rochester, New York. ... The University of Queensland (UQ) is the longest-established university in the state of Queensland, Australia, a member of Australias Group of Eight, and the Sandstone Universities. ... The National Cancer Institute (NCI) is part of the United States Federal governments National Institutes of Health. ...


Indications

Cervarix is a preventative cervical cancer vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV strains other than HPV 16, 18, 31 and 45, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated.


Administration

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil.[6] Phase III trials included over 660 women from Germany and Poland. Company officials are now conducting a clinical trial to determine whether Cervarix is more effective than rival Merck's HPV vaccine Gardasil.[7] North America North America is a continent[1] in the Earths northern hemisphere and (chiefly) western hemisphere. ... Gardasil is a vaccine against certain types of the human papillomavirus (HPV), based on technology created by workers at University of Rochester. ...


Longevity of the vaccination has proven so far to be at least 5.5 years.[8] In the clinical trials, women were given three doses over a six-month span -- at 0 month, 1 month, and 6 months. The technology used in this vaccine was licensed from the University of Rochester.[9] The University of Rochester (UR) is a private, coeducational and nonsectarian research university located in Rochester, New York. ...


On March 29, 2007 GlaxoSmithKline submitted a Biologics License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), to the FDA which included data from clinical trials in almost 30,000 females 10 to 55 years of age and contains data from the largest Phase III cervical cancer vaccine efficacy trial to date.[10] is the 88th day of the year (89th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ...


Cervarix in Manila

On august 25, 2007 GlaxoSmithKline (GSK) launched its Cervarix anti-cervical cancer vaccine in the Philippines after approval by the local Bureau of Food and Drugs which also approved a similar vaccine Gardasil (15,000 pesos or US$320; euro235 for 3 doses, produced by U.S.-based drug company Merck & Co. (MRK) on 2006). Cervarix fights types 16 and 18 of the human papillomavirus which cause 70% of cervical cancer worldwide.[11] Professor Cecilia Llave, University of the Philippines' Cancer Institute head reported that yearly, 6,000 women develop cervical cancer in Philippines and about 4,300 of them die from the disease. In Asia Pacific, it is the 2nd most common female cancer (266,000 women affected yearly, killing 140,000).[12] GlaxoSmithKline plc (LSE: GSK NYSE: GSK) is a British based pharmaceutical, biological, and healthcare company. ... Gardasil is a vaccine against certain types of the human papillomavirus (HPV), based on technology created by workers at University of Rochester. ... Merck may refer to: Merck & Co. ... Species See text Papillomaviruses are viruses that commonly cause warts. ... Cervical cancer is a malignant cancer of the cervix. ... The Oblation UP Diliman, the flagship campus of the U.P. System UP Baguio UP Extension Program in Pampanga Temporary Campus UP Los Baños UP Manila This article is about the University of the Philippines System. ... This article is about the medical term. ... Map showing general definition of Asia-Pacific The term Asia-Pacific generally applies to littoral East Asia, Southeast Asia and Australasia near the Pacific Ocean, plus the states in the ocean itself (Oceania). ...


References

  1. ^ Glaxo cervical cancer shot approved in Australia Reuters (2007-05-21) Retrieved on 2007-05-25
  2. ^ D'Souza, Gypsyamber (May 10, 2007). "Case–Control Study of Human Papillomavirus and Oropharyngeal Cancer". New England Journal of Medicine 356: 1944-1956. 
  3. ^ New data show Cervarix™, GSK’S HPV 16/18 cervical cancer candidate vaccine, is highly immunogenic and well-tolerated in women over 25 years of age. GlaxoSmithKline (2006-06-05). Retrieved on 2007-01-27.
  4. ^ Cervarix(TM). Emory University (2006-08-21). Retrieved on 2007-01-27.
  5. ^ Who Invented the VLP Cervical Cancer Vaccines? McNeil, C., Journal of the National Cancer Institute, 2006, 98(7): 433.
  6. ^ Kresge, Kristen Jill (January, 2006). Cervical cancer vaccines. International AIDS Vaccine Initiative. Retrieved on 2006-08-28.
  7. ^ GSK Announces Trial To Compare Effectiveness Of Gardasil And Cervarix. Vaccine Rx (February 2007). Retrieved on 2007-02-04.
  8. ^ Cervarix Adjuvant System Effective for 5 + Years. Vaccine Rx (April 18, 2007). Retrieved on 2007-04-19.
  9. ^ Swingle, Chris (August 24, 2006). Parents face moral issues. The Ithaca Journal. Retrieved on 2006-08-28.
  10. ^ Cervarix - Glaxo HPV Vaccine Filed With FDA. Vaccine Rx (March 29, 2007). Retrieved on 2007-03-30.
  11. ^ GMA NEWS.TV, Second vaccine vs cervical cancer virus launched in Manila
  12. ^ CNNMoney.com, Vaccine That Fights Cervical Cancer Virus Launched In SE Asia

Reuters Group plc (LSE: RTR and NASDAQ: RTRSY); pron. ... The New England Journal of Medicine (New Engl J Med or NEJM) is a peer-reviewed medical journal published by the Massachusetts Medical Society. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... is the 27th day of the year in the Gregorian calendar. ... Emory University is a private university located in the metropolitan area of the city of Atlanta and in western unincorporated DeKalb County, Georgia, United States. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... is the 27th day of the year in the Gregorian calendar. ... A Public-private partnership dedicated to producing a preventive vaccine against HIV infection, suitable for use in the most affected developing countries. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ... is the 240th day of the year (241st in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... is the 35th day of the year in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... is the 109th day of the year (110th in leap years) in the Gregorian calendar. ... The Ithaca Journal is a daily morning broadsheet newspaper published in Ithaca, New York. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ... is the 240th day of the year (241st in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era. ... is the 89th day of the year (90th in leap years) in the Gregorian calendar. ...

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