GlaxoSmithKline announced new Phase III data show that at 18 months after the first of a three-dose regimen, 100 per cent of women up to age 55 vaccinated with the GlaxoSmithKline (GSK) cervical cancer candidate vaccine had antibodies present against the two most common cancer-causing human papillomavirus types, 16 and 18.
These data indicate that the vaccine, formulated with a proprietary adjuvant system called AS04, is highly immunogenic and generally well-tolerated, with antibody levels at least 10 times greater than those produced by natural infection.
These new extended follow-up data were presented at the American Society of Clinical Oncology (ASCO) annual meeting (abstract #3007).
?Previous natural infection with these cancer-causing human papillomavirus types may not confer lifelong protection. Thus, women of all ages may be at risk for future infection,? said Prof. Tino F. Schwarz, Stiftung Juliusspital, Wuerzburg, Germany, the lead study investigator.?In fact, the older a woman is when infected, the more likely that the infection will become persistent, which may lead to the development of precancerous lesions. These GSK cervical cancer vaccine study results suggest that many women could potentially benefit from vaccination against cervical cancer.?
Furthermore, the study shows that antibody levels in women ages 26 to 55 against cancer-causing virus types 16 and 18 were in the same range as observed in a separate study. That study demonstrated that the GSK cervical cancer vaccine provided 100 per cent sustained protection against precancerous lesions caused by these virus types for up to 5.5 years in women ages 15 to 25.
?The results of this study are very promising, as we observed that 100 percent of women in all age groups showed a persistent antibody response to our vaccine,? said Barbara Howe, MD, Vice President and Director, North American Vaccine Development Organization, GlaxoSmithKline. ?As women age, their immune responses typically decline. 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.?