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Quadrivalent HPV vaccine effective against genital warts in young males
Giuliano AR.N Engl J Med. 2011;364.401-411.
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The quadrivalent human papillomavirus vaccine protected against types 6, 11, 16 and 18 and against genital warts in males aged 16 to 26 years, according to recently published data.
For the randomized, placebo-controlled, double blind trial, researchers pooled data on 4,065 males aged 16 to 26 years, residing in 18 countries.
Primary outcome measure was whether the quadrivalent HPV vaccine (Gardasil, Merck) reduced the incidence for external genital lesions associated with HPV types 6, 11, 16 or 18. Study participants in the per-protocol group received all three vaccinations and were negative for relevant HPV types at enrollment. Participants in the intention-to-treat analysis received vaccine or placebo — regardless of baseline HPV status.
Compared with 89 external genital lesions identified in males included in the intention-to-treat group assigned placebo, 36 lesions were identified in those assigned the vaccine (95% CI, 40.8-73.8). Specifically, the efficacy was 65.5% (95% CI, 45.8-78.6) for HPV type 6-, 11-, 16- or 18-associated lesions.
Efficacy against lesions associated with HPV types 6, 11, 16 or 18 was 90.4% (95% CI, 69.2-98.1) in the per-protocol group. The researchers said injection-site pain was significantly more frequent among males assigned the quadrivalent vaccine vs. those assigned placebo (57% vs. 51%; P<.001).
Disclosures: Drs. Giuliano, Ferris, Moreira, Penny and Palefsky report receiving grant support from Merck; Dr. Penny receives grant support from GlaxoSmithKline; Dr. Goldstone receives grant support from Qiagen; Drs. Giuliano, Ferris, Moreira, Hillman and Chang receive speaking fees or fees for board membership from Merck; Dr. Moi reports that his institution has received funding from Merck; Dr. Penny reports having stock or stock options in AstraZeneca; Dr. Palefsky receives consulting fees from GlaxoSmithKline; Drs. Giuliano, Palefsky, Goldstone, Moreira, Moi and Chang receive travel reimbursement from Merck; Dr. Bryan has an approved, filed or pending patent related to subject matter discussed in this article; and Drs. Bryan, Marshall, Vuocolo, Barr, Haupt, Guris and Mr. Radley are employees of Merck and own Merck stock or stock options.
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