Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
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DOI：
10.1056/nejmoa0909537
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发表时间：
2011-02-03
期刊：
影响因子：
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通讯作者：
Guris D
中科院分区：
文献类型：
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作者：
Giuliano AR;Palefsky JM;Goldstone S;Moreira ED Jr;Penny ME;Aranda C;Vardas E;Moi H;Jessen H;Hillman R;Chang YH;Ferris D;Rouleau D;Bryan J;Marshall JB;Vuocolo S;Barr E;Radley D;Haupt RM;Guris D
人乳头瘤病毒（HPV）感染和由HPV引起的疾病在男孩和男人中很常见。我们报告了四价疫苗（对HPV 6、11、16和18型有效）的安全性及其在预防男孩和男性外生殖器病变和肛门生殖器HPV感染方面的有效性。我们在一项随机、安慰剂对照、双盲试验中招募了来自18个国家的4065名16至26岁的健康男孩和男性。主要有效性目标是显示四价HPV疫苗降低与HPV-6、11、16或18相关的外生殖器病变的发生率。在符合方案人群和意向治疗人群中进行了疗效分析，其中受试者接受了所有三种疫苗接种，并且在入组时相关HPV类型为阴性，其中受试者接受了疫苗或安慰剂，无论基线HPV状态如何。在意向治疗人群中，疫苗组有36例外生殖器病变，而安慰剂组有89例，观察到的疗效为60.2%（95%置信区间[CI]，40.8至73.8）;对于HPV-6、11、16或18相关病变，疗效为65.5%（95% CI，45.8至78.6）。在符合方案人群中，对HPV-6、11、16或18相关病变的疗效为90.4%（95% CI，69.2 - 98.1）。对于HPV-6、11、16或18持续感染以及在任何时间检测相关DNA的有效性为47.8%（95% CI，36.0 - 57.6）和27.1%（95% CI，16.6 - 36.3），符合方案人群分别为85.6%（97.5% CI，73.4 - 92.9）和44.7%（95% CI，31.5 - 55.6）。注射部位疼痛在接受四价HPV疫苗的受试者中明显比接受安慰剂的受试者更常见（57% vs. 51%，P<0.001）。四价HPV疫苗可预防16至26岁男性感染HPV-6、11、16和18以及相关外生殖器病变。（由默克和其他公司资助; ClinicalTrials.gov编号，NCT 00090285。）
Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We 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. We 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. 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% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) 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% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) 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%, P<0.001). 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. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.)