New data in women 15 to 55 years of age show that the GlaxoSmithKline (GSK) cervical cancer candidate vaccine induces an immune response to cancer-causing human papillomavirus types 16 and 18 in the bloodstream which highly correlates to antibody levels in the cervico-vaginal secretions. Furthermore, these antibodies to cancer-causing virus types 16 and 18 were detected and sustained for one year following completion of the vaccination course. These data were presented Tuesday at the AmericanCollegeof Obstetrics and Gynecology (ACOG) annual meeting.“Cancer-causing human papillomavirus is very effective at hiding from the immune system because it exists within the cervical epithelium, away from the bloodstream,” said Prof. Dr. Tino F. Schwarz, Stiftung Juliusspital Wuerzburg, Germany, the lead study investigator. “This emphasizes the need for a cervical cancer vaccine to be effective in the cervix, at the site of infection. These data show there is a correlation between the vaccine inducing high antibody levels to the cancer-causing virus types in the bloodstream and the presence of antibodies in cervico-vaginal secretions, potentially providing antibodies where they are needed most.”
This study is a subset of data from 90 women participating in a larger, open, age-stratified trial of 666 women between 15 to 55 years of age. Blood samples were collected at several time points after the first vaccine dose, and cervico-vaginal secretions were collected at 18 months. Samples were measured for immune response against cancer-causing virus types 16 and 18. Results from the study show that antibodies to cancer-causing virus types 16 and 18 in the cervico-vaginal secretions were detected across all age groups.
The results also show that antibody levels in the bloodstream were in the same range as those seen in a separate efficacy study of females 15 to 25 years of age, which indicate that the GSK cervical cancer candidate vaccine has shown to provide in the trials a 100 percent efficacy for 5.5 years in preventing precancerous lesions due to cancer-causing virus types 16 and 18.
“These results are exciting, as they confirm that the higher the antibody levels in the blood, the higher the levels in the cervico-vaginal secretions, and present at the site of infection, where they are needed most,” said James Tursi, M.D., Director of Medical Affairs, North Americaat GlaxoSmithKline. “These data are critical in helping us to better understand how our cervical cancer candidate vaccine formulated with the novel adjuvant, AS04, helps provide protection against cancer-causing virus types.”
About Cervical Cancer
After breast cancer, cervical cancer is the leading cause of cancer-related death in women between the ages of 20 to 39 in the United States. The American Cancer Society estimates that in 2007 more than 11,000 women will be diagnosed with cervical cancer and nearly 4,000 will die from this disease in the United States. Furthermore, approximately 2 million precancerous lesions are diagnosed each year in the United States.
About The GSK Cervical Cancer Candidate Vaccine
GSK submitted aBiologics License Application for CERVARIX® with the U.S. Food and Drug Administration in March 2007. In addition, GSK has submitted a marketing authorization application to the European Medicines Agency, Australia, Canada, and numerous countries in Asiaand Latin America.
About GlaxoSmithKline
GlaxoSmithKline—one of the world’s leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media
GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatricvaccines which protect the world’s children with up to six diseases in one vaccine.
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