( samples. -- When using the pre-s...)Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix,Provides Excellent Protection Against Lesions Caused by Most Common,Cancer-Causing Virus Types,Health

    -- When using the pre-specified analyses which only required detection of

       virus in the lesion, and not taking previous samples into account,

       vaccine efficacy in women with virus type 16 and/or 18 in the lesion

       was 90 percent.

    -- When considering the virus type present in both the lesion and previous

       samples, the vaccine was 100 percent effective in preventing

       precancerous lesions caused by virus types 16 and/or 18.

"The findings are very encouraging because the women in the study are representative of the patients seen by physicians every day in their practice," said lead investigator Professor Jorma Paavonen, Department of Obstetrics and Gynecology at Helsinki University Central Hospital, Finland. "This provides a strong indication that this vaccine can protect women from the infections that may develop into cervical cancer."

This pivotal, Phase III study involves 18,644 women aged 15 to 25 from 14 countries across Europe, Asia-Pacific and Latin and North America, making it the single largest cervical cancer vaccine efficacy trial to date.

Cross protection

In this clinical trial, the vaccine showed significant cross-protection against 6-month persistent infection caused by virus types 45, 31 and 52. Together with virus types 16 and 18, these types are collectively responsible for more than 80 percent of cervical cancer cases globally.

"These results suggest protection from persistent infection with additional cancer-causing virus types beyond those contained in the vaccine," said Professor Margaret Stanley, Pathology Department, University of Cambridge, UK. "This is important because persistent infection is a necessary first step in the development of precancerous lesions and cervical cancers."

The data also shows that the GSK candidate vaccine, formulated with the innovative adjuvant system AS04, produced a robust immune response for both virus types 16
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