Re: Efficacy of quadrivalent human papillomavirus vaccine against human papillomavirus infection and disease in males

摘要

In their original paper, Giuliano and coworkers report the results of an 18-country, randomized, placebo-controlled, double-blind study aimed at evaluating the efficacy of the quadrivalent human papillomavirus (HPV) vaccine against external genital lesions and anogenital infection in males aged 16-26 yr. Their findings showed that the vaccine promoted an efficacy of 65.5% in terms of external genital lesions (mostly condylomata acuminata) when considering the intent-to- treat population; moreover, the efficacy rate even increased up to 90.4% in the per-protocol population for lesions related to the four types of HPV specifically covered by the vaccine (ie, HPV 6, 11, 16, and 18). Although still very high, the efficacy was higher in heterosexual men as compared with individuals who had sex with male partners (92.4% vs 79%, respectively). Moreover, quadrivalent HPV vaccine promoted an overall reduction of 85.6% in persistent infection with HPV 6,11, 16, or 18. Injection-site adverse events were significantly more frequent among those men who had received quadrivalent HPV vaccine as compared with those receiving placebo. Conversely, the rate of treatment-emergent systemic adverse events did not differ between groups, and no serious adverse events were eventually related to the vaccine.