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In October 2009, on the basis of this international manufacturer-supported trial, the FDA approved the quadrivalent human papillomavirus (HPV) vaccine (Gardasil) for preventing genital warts in boys and young men.
More than 4000 boys and men (age range, 16–26) received three injections of HPV vaccine or placebo during 6 months. Overall, at a median follow-up of 3 years, the incidence of external genital lesions was about 60% lower in the vaccine group. In a subset of participants who were initially seronegative for some or all vaccine serotypes, almost all vaccine recipients seroconverted after vaccination, and the overall incidence of external genital lesions in this group was >80% lower than that among placebo recipients.
Participants also …