March 8, 2009

HPV Vaccine Effective in Males


HPV Vaccine Effective in Males

Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), the vaccine approved for the prevention of cervical cancer and other HPV-related conditions in women, has now been shown to prevent genital lesions in men ages 16 to 26. The results of this pivotal Phase III study were presented at the November 12-15, 2008 European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference in France.[1]

Human papillomaviruses (HPV) consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer. The types of HPV most commonly linked with cervical cancer are HPV 16 and HPV 18, but several other high-risk types contribute to cancer as well.

The types of HPV that cause cervical cancer or genital warts are transmitted sexually. HPV infection is extremely common and generally occurs soon after an individual becomes sexually active. Although most infections resolve on their own, some persist and can lead to precancerous or cancerous changes to the cervix, vulva, vagina, penis, and anus.

Gardasil is already approved for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18 in girls and young women nine through 26 years of age. Male HPV can lead to genital warts, penile cancer, perianal cancer, anal cancer, and perineal cancer. In addition, it contributes to HPV infection in women and subsequent cervical disease, including cervical cancer. Although males can spread the virus and many other countries have approved the vaccine for use in males, it has not been approved for males in the United States because to date there has been no evidence that it prevented disease in men.

In a study conducted at the H. Lee Moffitt Cancer Center, 4,065 men between the ages of 16 and 26 who had not been infected with HPV were randomized to receive three doses of Gardasil or placebo (upon enrollment, at two months, and at six months). The subjects then underwent detailed exams at enrollment, month seven, and every six months thereafter for 36 months. There were three cases of genital warts in the vaccine group versus 31 cases in the placebo group. There were no cases of penile/perineal/perianal intraepithelial neoplasia (PIN) (which can be a precursor to cancer) in the vaccine group versus three cases in the placebo group. There were no cases of penile cancer in either the vaccine or the placebo groups. As a result the researchers concluded that Gardasil was 90% effective in preventing genital warts.

These are promising results and warrant more research into the vaccination of boys against HPV.


[1] Giuliano A, Palefsky J, et al. The efficacy of quadrivalent HPV (types 6/11/16/18) vaccine in reducing the incidence of HPV infection and HPV-related genital disease in young men. Presented at the European Research Organization on Genital Infection and Neoplasia International Multidisciplinary Conference, Nice-Acropolis France, November 12-15, 2008. Abstract #SS 19-7.

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