Efficacy of quadrivalent HPV vaccine in males

January 01, 0001

Efficacy of quadrivalent HPV vaccine in males

These authors from multiple countries report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. They enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo- controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to- treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status.

They found: "In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2%; the efficacy was 65.5% for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4%. Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% and 27.1%, respectively, in the intention- to-treat population and 85.6% and 44.7% in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%)."

The authors concluded: "Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age."

These results are as expected since the vaccine is also known to be effective in women.

For the full abstract, click here.

N Engl J Med 364:401-411, 3 February 2011 © 2011 to the Massachusetts Medical Society
Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males. Anna R. Giuliano, Joel M. Palefsky, Stephen Goldstone, et al. Correspondence to Dr. Giuliano: [email protected]

Category: Y. Male Genital System, Breast, B. Blood/Blood Forming Organs/Immune Keywords: human pappilomavirus, HPV, vaccine, genital lesions, males, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 15 February 2011

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