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THE EFFFICACY OF QUADRIVALENT HPV (TYPES 6/11/16/18) VACCINE AGAINST HPV-RELATED GENITAL DISEASE AND INFECTION IN YOUNG MEN
 
 
  25th International Papillomavirus Congress
May 8-14, 2009, Malmo, Sweden
Presentation O-01.07
Reported by Jules Levin
 
Giuliano AR1, Palefsky J2, on behalf of the Male Quadrivalent HPV Vaccine Efficacy Trial Study Group
 
1. Risk Assessment, Detection, and Intervention Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa FL; 2. Department of Medicine, University of California, San Francisco
 
"The quadrivalent HPV vaccine is efficacious in reducing the burden of HPV 6/11/16/18-related EGL (external genital lesions) and infection in young men aged 16-26 years na•ve to the relevant HPV type at baseline."
 

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ABSTRACT
 
BACKGROUND:
In males, anogenital infection with human papillomavirus (HPV) can lead to genital warts, penile, perineal, perianal, and anal neoplasia and cancer. In addition, male HPV infection contributes significantly to infection and subsequent cervical disease in women.
 
OBJECTIVE: This study examined the efficacy of the quadrivalent HPV (type 6/11/16/18) L1 virus-like particle vaccine against incidence of HPV 6/11/16/18-related external genital lesions (EGL) (external genital warts, penile/perineal/perianal intraepithelial neoplasia, and penile/perineal/perianal cancer) as well as genital HPV 6/11/16/18 infection in young men (heterosexual men and men having sex with men).
 
METHODS: In this randomized, double-blind, placebo-controlled trial, 4,065 young men aged 16-26 years were administered quadrivalent HPV vaccine or placebo at enrollment, month 2, and month 6. Subjects underwent detailed genital exams as well as sampling from the penis, scrotum, and perineal/perianal region at enrollment, month 7 and at 6-month intervals afterwards. After enrollment, all new lesions were biopsied for pathological diagnosis and PCR testing. Efficacy analyses were performed in a per-protocol population seronegative at day 1 and HPV DNA-negative from day 1 through month 7 to the relevant vaccine HPV type. Median follow-up was 2.3 years (starting from month 7).
 
RESULTS:
Among 1,397 vaccine subjects and 1,408 placebo subjects, efficacy against any HPV 6/11/16/18-related external genital lesion was 90.4% (95% CI: 69.2, 98.1).
 
Vaccine efficacy against condyloma and PIN was 89.4% (95% CI: 65.5, 97.9) and 100% (95% CI: <0, 100), respectively.
 
Vaccine efficacy against HPV 6/11/16/18 persistent infection and DNA detection at one or more visits was 85.6% (97.5% CI: 73.4, 92.9), and 44.7% (95% CI: 31.5, 55.6), respectively.
 
Slightly more injection-site adverse experiences were seen among vaccine recipients.
 
CONCLUSION: The quadrivalent HPV vaccine is efficacious in reducing the burden of HPV 6/11/16/18-related EGL and infection in young men aged 16-26 years na•ve to the relevant HPV type at baseline.
 
BACKGROUND
 

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