Sexual Health Buzz

Recent results of a Phase III clinical trial involving Gardasil, a vaccine against four strains of human papillomavirus (HPV), indicate that the vaccine may help prevent genital warts in boys and men. Results of the study, funded by Merck, the manufacturer of Gardasil, were presented earlier this month at the annual meeting of the European Research Organization on Genital Infection and Neoplasia (EUROGIN).

Currently in the U.S., Gardasil is only approved for use in for girls and women aged 9-26. Yet while the vaccine provides protection against two strains of HPV associated with 70 percent of cervical cancer in females, it also protects against strains of HPV that cause genital warts that HPV Newseffect both males and females. The study evaluated approximately 4000 males between 16 through 23 years of age. Study participants received either three doses of Gardasil at regular intervals or a placebo. All participants were followed for 36 months. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.

Participants who were vaccinated with Gardasil were approximately 90 percent less likely to develop genital warts than those that received a placebo. No study participants experienced any serious side effects related to vaccination. Merck intends to submit a supplemental Biologics License Application for Gardasil to the FDA by the end of 2008 for the use of the vaccine in boys and men ages 9 to 26 for the prevention of genital warts.

ASHA’s fact sheet on HPV vaccines addresses some of the most common questions about Gardasil and other vaccines in development. ASHA’s website also offers recent data on the safety of Gardasil.

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