GSK's Experimental HPV Vaccine Cervarix Produces Immune Response In 100% Of Women 18 Months After First Dose, Company Says

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 10 Jun 2007 - 9:00 PDT

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GlaxoSmithKline's experimental human papillomavirus vaccine Cervarix produces an immune response in 100% of women 18 months after they receive the initial dose of the vaccine, the company announced Tuesday at a meeting of the American Society of Clinical Oncology in Chicago, AFX/Forbes reports (Brown, AFX/Forbes, 6/5).

Cervarix and Merck's HPV vaccine Gardasil have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Researchers in a 2006 study published in the online edition of the Lancet also found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases. GSK in January announced that it would begin a trial to determine whether Cervarix provides better protection against cervical cancer than Gardasil (Kaiser Daily Women's Health Policy Report, 5/31).

GSK said that data from a follow-up study of 517 women and girls ages 15 to 55 found that Cervarix provided 10 times higher antibody levels against HPV strains 16 and 18 than those produced by natural infection 18 months after the participants received their first dose of the three-dose regimen, Dow Jones reports (Berton, Dow Jones, 6/5). According to a GSK release, the observed antibody levels among women ages 26 to 55 were in the same range as observed levels of women enrolled in another study of the vaccine.

"As women age, their immune responses typically decline," Barbara Howe, vice president and director of GSK's North American Vaccine Development Organization, said, adding, "We designed our cervical cancer vaccine with an adjuvant system, called AS04, which is specifically intended to enhance immune response and increase duration of protection" (GSK release, 6/5). Study lead researcher Tino Schwarz of Stiftung Juliusspital in Wuerzburg, Germany, "These ... results suggest that many women could potentially benefit from vaccination against cervical cancer" (Dow Jones, 6/5).

The Australian Therapeutic Goods Administration last month granted the first major market license for Cervarix, approving the vaccine for girls and women ages 10 to 45. The European Medicines Agency could recommend the vaccine this month. FDA has granted a standard 10-month review of Cervarix and will most likely take action on GSK's application in January 2008, according to analysts at Evolution Securities (Kaiser Daily Women's Health Policy Report, 5/31).

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