(1888PressRelease)
May 09, 2009 - Comparative trial of Cervarix® and Gardasil® (Study 010)
Results from the first, large-scale comparative trial between licensed human papillomavirus (HPV) vaccines show that Cervarix® generated a significantly higher immune response compared to Gardasil® .1
The comparative study looked at two key measures of immune response, neutralising antibodies and memory B cells. Although the post-vaccination immune correlates of protection for cervical cancer are still unknown, neutralising antibodies and B cells are believed to play an important role in protecting women from HPV infection and subsequent cervical cancer over the long term.2-7 Across all ages studied (women 18 – 45 years), neutralising antibody levels for Cervarix ® were more than two times higher than those for Gardasil ® for HPV type 16, and more than six times higher for HPV type 18.
These results were highly statistically significant. In addition, the proportion of women with detectable levels of neutralising antibodies in cervical secretions was higher in the group that received Cervarix® Compared toGardasil® , GSK’s vaccine also produced nearly three (2.7) times more memory B cells for HPV types 16 and 18.
Compliance with the full vaccination course was high and comparable for both vaccines8 which indicates that both were well tolerated. Rates of solicited symptoms were higher for Cervarix® with injection site reactions being most common.8 However, in both groups solicited symptoms tended to be of short duration. It is expected that the full results from this comparative study will be published in a peer reviewed journal.
Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: “The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types. We are confident that these results, along with new results from additional key studies being presented this week, demonstrate the potential of Cervarix®.”
Phase III efficacy trial (Study 008)
Results from the final analysis of the Phase III study (HPV-008) will be presented for the first time at the conference, showing that Cervarix® provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18).9 In addition,the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18.10 In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.11
Rates of serious adverse events and medically significant conditions were similar between study and control groups.9 These data have been submitted to regulatory authorities including the US FDA and publication is expected in a peer reviewed journal.
Long term follow up study (Study 023)
Results from a third study to be presented in Malmö show that GSK`s cervical cancer vaccine provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine.12
Jean Stéphenne, President and General Manager of GlaxoSmithKline Biologicals said, “Preventing cervical cancer is a public health priority in both developed and developing countries. We are pleased with these findings and how they can further the understanding of the role of Cervarix ® in helping to protect women against cervical cancer."
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 further information please visit www.gsk.com
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