四价人乳头瘤病毒（HPV）疫苗在男性 HPV 感染和疾病中的功效。
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
机构信息
Risk Assessment, Detection, and Intervention Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.
出版信息
N Engl J Med. 2011 Feb 3;364(5):401-11. doi: 10.1056/NEJMoa0909537.
BACKGROUND
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.
METHODS
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.
RESULTS
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).
CONCLUSIONS
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.).
背景
人乳头瘤病毒（HPV）感染和 HPV 引起的疾病在男孩和男性中很常见。我们报告了一种四价疫苗（针对 HPV 型 6、11、16 和 18 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 感染方面的疗效。
方法
我们在 18 个国家招募了 4065 名 16 至 26 岁的健康男孩和男性，进行了一项随机、安慰剂对照、双盲试验。主要疗效目标是证明四价 HPV 疫苗可降低与 HPV-6、11、16 或 18 相关的外生殖器病变的发病率。在方案人群和意向治疗人群中进行了疗效分析，方案人群中，所有受试者均接受了三次疫苗接种，且在入组时均未检测到相关 HPV 型；意向治疗人群中，无论基线 HPV 状态如何，所有受试者均接受了疫苗或安慰剂治疗。
结果
在意向治疗人群中，疫苗组有 36 例外生殖器病变，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）；与 HPV-6、11、16 或 18 相关的病变的疗效为 65.5%（95% CI，45.8 至 78.6）。方案人群中，针对 HPV-6、11、16 或 18 相关病变的疗效为 90.4%（95% CI，69.2 至 98.1）。在意向治疗人群中，HPV-6、11、16 或 18 的持续性感染和任何时候的相关 DNA 检测的疗效分别为 47.8%（95% CI，36.0 至 57.6）和 27.1%（95% CI，16.6 至 36.3），方案人群中的疗效分别为 85.6%（97.5% CI，73.4 至 92.9）和 44.7%（95% CI，31.5 至 55.6）。与接受安慰剂的受试者相比，接受四价 HPV 疫苗的受试者注射部位疼痛明显更为常见（57% vs. 51%，P<0.001）。
结论
四价 HPV 疫苗可预防 16 至 26 岁男性 HPV-6、11、16 和 18 的感染和相关外生殖器病变的发生。（由默克公司及其它公司资助；临床试验注册号：NCT00090285）。
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