Cervarix

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See also: HPV vaccine

Cervarix is a vaccine against certain types of the human papillomavirus (HPV) that cause cervical cancer, manufactured by GlaxoSmithKline. It is designed to prevent infection from HPV types 16 and 18, which currently cause about 70% of cervical cancer cases. Type 16 has also been found to be associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.[1] Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials.[2] 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.[3]

Contents

[edit] 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.[4]

[edit] 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.

[edit] Clinical trials

Phase II trials demonstrated 100% protection of the vaccine against types 16 and 18 HPV, including among 1100 women from North America and Brazil.[5] 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.[6]

Longevity of the vaccination has proven so far to be at least 5.5 years.[7] 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.[8]

[edit] Regulatory Approval

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.[9]

  • It received approval in May 2007 in Australia for women ages 10 to 45.[10]
  • On August 25, 2007 GlaxoSmithKline launched Cervarix in the Philippines after approval by the local Bureau of Food and Drugs.[11]

[edit] See also

[edit] References

  1. ^ D'Souza, Gypsyamber (May 10, 2007). "Case–Control Study of Human Papillomavirus and Oropharyngeal Cancer". New England Journal of Medicine 356: 1944–1956. doi:10.1056/NEJMoa065497. PMID 17494927. 
  2. ^ 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.
  3. ^ Cervarix(TM). Emory University (2006-08-21). Retrieved on 2007-01-27.
  4. ^ Who Invented the VLP Cervical Cancer Vaccines? McNeil, C., Journal of the National Cancer Institute, 2006, 98(7): 433.
  5. ^ Kresge, Kristen Jill (January, 2006). Cervical cancer vaccines. International AIDS Vaccine Initiative. Retrieved on 2006-08-28.
  6. ^ GSK Announces Trial To Compare Effectiveness Of Gardasil And Cervarix. Vaccine Rx (February 2007). Retrieved on 2007-02-04.
  7. ^ Cervarix Adjuvant System Effective for 5 + Years. Vaccine Rx (April 18, 2007). Retrieved on 2007-04-19.
  8. ^ Swingle, Chris (August 24, 2006). Parents face moral issues. The Ithaca Journal. Retrieved on 2006-08-28.
  9. ^ Cervarix - Glaxo HPV Vaccine Filed With FDA. Vaccine Rx (March 29, 2007). Retrieved on 2007-03-30.
  10. ^ Glaxo cervical cancer shot approved in Australia Reuters (2007-05-21) Retrieved on 2007-05-25
  11. ^ GMA NEWS.TV, Second vaccine vs cervical cancer virus launched in Manila

[edit] External links

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