Efficacy of GARDASIL® against External Genital Lesions Due to 14 HPV Types in Men

Background: Quadrivalent HPV (types 6/11/16/18) vaccine (qHPV vaccine; GARDASIL®) is 90% (95% CI: 69, 98) efficacious against vaccine HPV type related external genital lesions (EGL) in men.

Objectives: To determine the efficacy of qHPV vaccine against EGL related to HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 55, 58, and 59 in men. 

Methods: Data are from 4,065 men aged 16-26 years enrolled in a double-blind, placebo-controlled trial.  Subjects received qHPV vaccine or placebo at day 1, months 2 and 6 and had genital exams and HPV sampling from penis, scrotum, and perineal/perianal area at day 1, month 7 and every 6 months. Subjects with visible or history of HPV related lesions were excluded at day 1. Efficacy was calculated in a population of subjects who were PCR negative to HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59 and seronegative to HPV6, 11, 16 and 18 at day 1, and received ≥1 dose of vaccine or placebo. Median follow up was 2.9 years.

Results: Among 1,275 vaccine and 1,270 placebo recipients, 42 developed EGL (6 vaccine and 36 placebo recipients).  Vaccine efficacy (VE) was 83.8% (95% CI: 61.2, 94.4) against EGL related to any HPV type.  31 (86%) and 3 (50%) EGL cases in the placebo and vaccine recipients were PCR positive for HPV 6, 11, 16, or 18, respectively.   VE against vaccine HPV types was 90.6% (95% CI: 69.8, 98.2). 

Conclusions: These data show the high efficacy of qHPV vaccine against vaccine-type EGL.  Efficacy data for non-vaccine type EGL were not conclusive due to small sample size. 

Implications for Programs, Policy, and/or Research: These data suggest a potential benefit of male vaccination with qHPV vaccine through prevention of EGL.