A new vaccine from Merck & Co could prove to be an exciting development in the fight against cervical cancer, according to Phase II data unveiled at the International Papillomavirus Conference in Vancouver, Canada, and presented in the latest issue of the journal Lancet Oncology. Results showed up to 90% protection against infection with the virus responsible for cervical cancer and genital warts – known as human papillomavirus.
The trial enrolled over 500 women who received either Gardasil or placebo at baseline and at months two and six. And, over the two and a half years’ follow-up, the vaccine was shown to cut infection with four subtypes of human papillomavirus (HPV 16, 18, 6 and 11) as well as related genital disease, including cervical pre-cancers and genital warts, by 90% versus placebo.
“The level of protection in this study against infection with these four HPV types, including pre-cancerous lesions, was momentous,” said Alex Ferenczy, one of the study authors and Professor of Pathology and Obstetrics/Gynecology at McGill University. “Though not originally designed to do so, the study showed that efficacy of the investigational vaccine against cervical pre-cancers caused by the HPV types 16, 18, 6 and 11 was 100%.”
Phase III clinical trials to evaluate Gardasil are currently underway with over 25,000 participants enrolled worldwide. Data are expected to be available later this year.
– Meanwhile, rival GlaxoSmithKline has also presented data at the International Papillomavirus Conference, showing its Cervarix vaccine offered broad protection against several strains of HPV – 16, 18, 31, 45 and 52. According to a Reuters report, these subtypes are responsible for 82% of cervical cancers. Cervarix is currently in the final stage of development, as is Merck’s offering, but is not expected to be filed for approval until 2006 as opposed to later on this year for Gardasil.
