GSK's HPV Vaccine Produces Immune Response In Women Ages 15 To 55, Study Says

GlaxoSmithKline's experimental human papillomavirus vaccine Cervarix -- which has been shown in studies to be 100% effective in preventing infection with HPV strains 16 and 18 -- produces an immune response in all women ages 15 to 55 one year after they received the vaccine, according to a study presented at an American Society of Clinical Oncology meeting on Tuesday in Atlanta, Dow Jones reports. Tino Schwarz, a professor at Stiftung Juliusspital-Wuerzburg in Germany and colleagues in a Phase III trial examined 666 women ages 15 to 55 who received three doses of Cervarix. The study included data from 437 women ages 26 to 55 (Corbett Dooren, Dow Jones, 6/5). According to the study, an antibody response was detected in 100% of the women seven months after receiving the first of three does of the vaccine and remained one year following the initial dose (Reuters, 6/5). In a previous study published in the April 6 online edition of the Lancet, women ages 15 to 25 who received Cervarix showed high levels of antibodies against HPV strains 16 and 18 for up to four-and-a-half years after receiving the vaccine. Researchers 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 (Kaiser Daily Women's Health Policy Report, 4/6). "For the first time, we see that a vaccine against cervical cancer is highly immunogenic in women over 25 years of age," Schwarz said, adding, "These are important data as older women remain at significant risk of acquiring infections with cancer-causing HPV types" (AFP/Yahoo! News, 6/6). GSK plans to file for approval with FDA by the end of this year. Philippe Monteyne, head of global vaccine development for GSK, said the company plans to submit the most recent study findings to FDA in hopes of gaining the agency's approval of the vaccine for women up to age 55 (Dow Jones, 6/5).pregnancy" (Los Angeles Times, 6/5).


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View drug information on Cervarix [Human Papillomavirus Bivalent.