WEDNESDAY, Feb. 2 (HealthDay News) -- Vaccination against human papillomavirus (HPV) appears effective in preventing HPV-6, 11, 16, and 18 as well as the development of external genital lesions in boys and men, according to research published in the Feb. 3 issue of the New England Journal of Medicine.
Anna R. Giuliano, Ph.D., of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., and colleagues randomized 4,065 boys and men 16 to 26 years of age to quadrivalent HPV vaccine or placebo to determine the safety and efficacy of the treatment in preventing external genital lesions and HPV infection in males.
In the intention-to-treat group, randomized to vaccine or treatment regardless of HPV status, 36 external genital lesions were seen in the vaccine group and 89 in the placebo group, for an efficacy of 60.2 percent. For lesions related to HPV-6, 11, 16, or 18, the efficacy was 65.5 percent. In the per-protocol population, who were HPV-negative at enrollment, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4 percent. With respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time, the efficacy was 47.8 and 27.1 percent, respectively, in the intention-to-treat population and 85.6 and 44.7 percent, respectively, in the per-protocol population. Pain at the injection site was significantly more frequent among those receiving the vaccine than those receiving placebo (57 versus 51 percent).
"Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age," the authors write.
The study was funded in part by Merck; several authors disclosed financial relationships with Merck and/or other pharmaceutical companies.
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