Study Finds HPV Vaccine Gardasil Effective At Preventing Male Genital Lesions

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Men's health;  Sexual Health / STDs
Article Date: 14 Nov 2008 - 7:00 PDT

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Merck's human papillomavirus vaccine Gardasil is about 90% effective in preventing external lesions -- mostly gential warts -- caused by the four HPV strains it targets and 45% effective in preventing HPV infection, according to a Merck-funded study, Reuters reports (Fox, Reuters, 11/12). Dow Jones reports that the study -- which is the first to demonstrate the efficacy of Gardasil in men -- likely will propel Merck to apply for FDA approval to market the vaccine to boys and men ages 9 to 26 for the prevention of external genital warts caused by HPV strains. Merck officials said the company is on track to seek the expanded approval by the end of the year (Loftus, Dow Jones, 11/13). The AP/Minneapolis Star Tribune reports that the vaccine first was licensed in 2006 and currently is approved for use in girls and women ages 9 to 26. Although males can spread HPV, it was not proven at that time that the vaccine could prevent certain or any strains of the virus in men. About 40 countries have approved Gardasil for use in men, but there "still is no medical proof Gardasil prevents penile cancer or other HPV-associated cancers in men," according to the AP/Star Tribune. In addition, there is "no evidence the vaccine prevents the spread of HPV from men to women," the AP/Star Tribune reports.

According to the AP/Star Tribune, the study involved about 4,000 men ages 16 to 26 from 20 countries -- including 1,000 men from the U.S. (Stobbe, AP/Minneapolis Star Tribune, 11/13). About half of the participants were given Gardasil, and about half received a placebo. Researchers tracked the rates of penile lesions, including genital warts, for 30 months. The study found three cases of external lesions in participants who were vaccinated and 31 cases in participants who were not vaccinated, for an efficacy rate of 90.4% (Dow Jones, 11/13). Researchers also examined rates of persistent HPV infection, finding 15 cases of persistent infection in the vaccinated group and 101 cases in the placebo group. The results will be presented Thursday at a medical conference in Europe.

Anna Giuliano, an epidemiologist at the H. Lee Moffitt Cancer Center in Tampa who worked on the study, said, "This opens the door to a wonderful opportunity to prevent the illness." However, Maura Gillison -- a researcher at Johns Hopkins University who was not involved in the study -- said that while the results are "exciting," it's not clear that the evidence is substantial enough to persuade parents of teenage males to have their children vaccinated. According to Lauri Markowitz, an HPV expert CDC, government officials are "eager[l]y" waiting for the study analysis from Merck. She added that the data is "obviously encouraging" but that "policy makers will be looking at a variety of different issues" (AP/Star Tribune, 11/13).

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