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Home HPV Vaccines HPV Vaccines HPV Vaccine Works in Males

HPV Vaccine Works in Males

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Results from a large multinational study show the quadrivalent HPV vaccine is effective in preventing a variety of genital lesions and persistent infections in males.

Merck’s Gardasil® vaccine covers HPV 16 and 18, the two HPV types found in most cervical and anal cancers (and many penile cancers) and the two “low risk” types (HPV 6 and 11) that cause about 90% of genital warts. Increasingly, HPV 16 is shown to play a role in the development of a number of head and neck cancers.

4055 subjects from 18 different countries were randomized to receive either vaccine or placebo. Participants were all healthy boys and young men between the ages of 16-26. The main end point of the study was vaccine efficacy in preventing external genital lesions (warts and penile, perianal, and perineal precancers and cancers). The investigators also looked at vaccine safety and effectiveness in preventing anogenital HPV infections.

Among subjects in the per protocol population (those who received all doses of the vaccine and were HPV-negative at the start of the study), effectiveness in preventing genital lesions related to the types of HPV covered by the vaccine was 90.4%. With the vaccine types, efficacy in blocking persistent HPV infections in this group was 85.6%.

Effectiveness in preventing vaccine-type genital lesions with the intent-to-treat group (those who received either vaccine or placebo regardless of HPV status) was 65.5%. In these subjects, Gardasil® was nearly 48% effective in preventing HPV infections with the viral types covered by the vaccine.

The most commonly reported adverse event was discomfort at the injection site, an effect reported more often among those in the vaccine group.

Gardasil® was approved in October 2009 for use with males ages 9-26 to prevent genital warts. In December 2010, the vaccine was approved for the prevention of anal cancers in both males and females.

The authors say while it’s likely HPV vaccination will prevent diseases such as anogenital and oropharyngeal cancers, along with HPV transmission, more research is needed for all this to be “directly demonstrated.”

Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone, Edson D. Moreira, Jr., Mary E. Penny,Carlos Aranda, Eftyhia Vardas, Harald Moi, Heiko Jessen, Richard Hillman, Yen-Hwa Chang, Daron Ferris, Danielle Rouleau, Janine Bryan,, J. Brooke Marshall, Scott Vuocolo, Eliav Barr, David Radley, Richard M. Haupt, and Dalya Guris. Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males. New England Journal of Medicine, 2011. 364:401-411.