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Quadrivalent HPV Vaccine Gardasil Reduces Persistent Anogenital HPV Infection in Men Who Have Sex With Men: Presented at IPV
  Data on the Use of GARDASIL in Men Presented at the 25th Annual International Papillomavirus Conference - (05/15/09)
By Bruce Sylvester
MALMO, Sweden -- May 15, 2009
Quadrivalent human papillomavirus (HPV) vaccine reduces anogenital HPV infection in young men who have sex with men (MSM), researchers reported here at the 25th International Papillomavirus (IPV) Conference.
"We found that in young men aged 16 to 26 years old, quadrivalent HPV vaccine is effective in reducing anogenital persistent HPV-6/11/16/18 and HPV-6/11/16/18 DNA detection," said Joel Palefsky, MD, University of California at San Francisco, San Francisco, California, on May 14. Anogenital HPV infection can cause neoplastic lesions, including genital warts and penile, perineal, perianal, and anal cancer. However, to date, no data have been available showing a benefit of HPV vaccination against the incidence of infection or genital disease in MSMs.
Researchers evaluated data from 602 MSMs, who were randomised 1:1 to receive the quadrivalent HPV vaccine or placebo at enrolment, 2 months, and 6 months.
Serum was collected at enrolment and 7, 24, and 36 months for analysis of anti-HPV antibodies.
Anogenital exams were conducted in all men, and DNA samples were taken from the penis, scrotum, perineal/perianal, and anal canal at enrolment and month 7 and at 6-month intervals thereafter.
Efficacy analyses were performed in a per-protocol population who were seronegative at day 1 and DNA-negative from day 1 through month 7 to the vaccine HPV type.
Median follow-up was 1 year after the third dose of vaccine.
The vaccine was 79.0% effective against HPV-6/11/16/18-related external genital lesions (EGL). Efficacy against the incidence of HPV-6/11/16/18 persistent infection and DNA detection at any visit was 94.4% (95% CI, 64.4-99.9) and 48.8% (95% CI, 11.6-71.2), respectively.
At 7 months, the investigators found that 96.5%, 97.4%, 94.2%, and 89.5% of the vaccinated subjects seroconverted for HPV-6, -11, -16, and -18, respectively.
"The quadrivalent HPV vaccine is effective in reducing the burden of anogenital HPV infection and EGL in young MSM. Further follow-up will provide additional cases that will increase the confidence of these observations," the researchers concluded.
Funding for this study was provided by Merck and Company.
[Presentation title: Quadrivalent HPV Vaccine Efficacy in Men Having Sex With Men. Oral Presentation O-27.01]
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