The Pharmaceutical Journal
Vol 269 No 7227 p802
7 December 2002

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Vaccine reduces risk of cervical cancer

Immunising women against human papillomavirus (HPV) type 16 infection could substantially reduce the incidence of cervical cancer, researchers say.

Dr Laura Koutsky, University of Washington, Seattle, and colleagues explain that the primary reason to immunise against HPV-16 infection is to prevent cervical cancer. They say that cervical cancer would be difficult to study for ethical and scientific reasons but that persistent HPV-16 infection is a reasonable surrogate end point since approximately 50 per cent of cervical cancers are associated with HPV-16 infection.

The researchers randomly assigned 2,392 women aged 16 to 23 years to receive three doses of either an HPV-16 virus-like particle vaccine or placebo at day zero, two months and six months. They found that the incidence of persistent HPV-16 infection, at a median of 17.4 months after completion of the vaccination regimen, was 0 per 100 woman-years at risk in the vaccine group and 3.8 per 100 woman-years at risk in the placebo group (95 per cent confidence interval, P<0.001). All of the 41 cases of HPV-16 infection occurred in the placebo group, nine of which were related to cervical intraepithelial neoplasm.

Although the vaccine was generally well tolerated, a slightly higher percentage of women in the vaccine group did not complete the vaccination regimen compared with the placebo group, the researchers say (New England Journal of Medicine 2002;347:1645).

The vaccine is being developed by Merck Sharp & Dohme and is currently being investigated in phase III trials for the prevention of four types of HPV infection.