To no one's surprise, a new clinical trial demonstrates that the human papilloma virus vaccine Gardasil is as good at protecting men as it is in protecting women, researchers reported Wednesday. A clinical trial in more than 4,000 boys and men demonstrated that the vaccine was more than 90% successful in preventing genital lesions caused by the four strains of HPV that the vaccine is active against, about the same level of protection demonstrated for women.
The vaccine is currently approved in the United States for both males and females over the age of 9, but current recommendations call for administration only to females. But the vaccine has been highly controversial, both because some view it as an implicit approval of sexual activity and because of its cost -- nearly $400 for a complete regimen of three doses. An estimated three-quarters of girls don't even start the regimen, and only about a third of those who do start it actually finish.
In the new trial, sponsored by the vaccine's manufacturer, Merck, Anna R. Giuliano of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., and her colleagues enrolled 4,065 healthy boys and men, ages 16 to 26, from 18 countries who were HPV-free and who reported one to five sexual partners. Half received the vaccine and half a placebo.