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Home HPV Vaccines HPV Vaccines Study: Gardasil® Effective in Males

Study: Gardasil® Effective in Males

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A Merck press release says that clinical trial data reported at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference in November indicates the company’s HPV vaccine, Gardasil®, reduced external lesions associated with HPV types 6, 11, 16, and 18 by 90% in boys and young men.

The Phase III trial involved nearly 4,000 males ages 16-23. The subjects were randomized into two groups, with half receiving Gardasil® and the remainder given placebo, and followed for 36 months.

Compared with placebo, the vaccine was 89.4 % effective in preventing external genital warts. Also, no cases of precancerous cell changes of the penis (penile interepithelial neoplasia, or PIN) were detected in the vaccine group (three cases occurred in the placebo group). No penile cancers were found in either group.

In this study, Gardasil® prevented over 85% of persistent HPV infections (defined as the same HPV type being detected at two or more visits over six months). The vaccine also prevented nearly 45% of “anytime” HPV infections, which are those detected at any visit.  

Merck says it intends to file an application with the FDA by the end of 2008 to have Gardasil®’s license expanded to include males ages 9-26. Currently, the vaccine is approved in the U.S. for prevention of cervical/vaginal/vulvar pre-cancers and cancers in women ages 9-26.