The recombinant human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine was effective at preventing genital warts in men 16 to 26 years old in phase 3 student results published in the New England Journal of Medicine.
The recombinant human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine was effective at preventing genital warts in men 16 to 26 years old in phase 3 study results published in the New England Journal of Medicine.
The study, the first to show that the vaccine works in males, included 4,065 boys and men who were randomized to 3 injections of HPV vaccine or placebo. Seroconversion for HPV-6, 11, 16, and 18 occurred in at least 97.4% of vaccine recipients within 1 month of the third dose.
At a median follow-up of 3 years, 36 external genital lesions were observed in the vaccine group compared with 89 in the placebo group, corresponding to a 60.2% lower incidence in the vaccine group.
The vaccine prevented genital lesions in heterosexual males and in those who had had sex with male partners, but the reduction in the incidence of genital lesions in the latter group did not achieve statistical significance.
"Although it is likely that the prevention of HPV infection will help prevent anogenital cancer, intraepithelial neoplasia, recurrent respiratory papillomatosis, and cancer of the oropharynx and HPV transmission, each of these potential outcomes must be directly demonstrated," write the investigators.
Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. NEJM. 2011;364(5):401-411.