Natural History of HPV Infection in Men: The HIM Study

男性 HPV 感染的自然史：HIM 研究

• 批准号: 6720429
• 负责人: Anna R. Giuliano
• 金额: $ 101.82万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-27 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6720429
• 关键词: Mexico; United States; behavioral /social science research tag; blood chemistry; clinical research; condoms; enzyme linked immunosorbent assay; human genetic material tag; human papillomavirus; human subject; humoral immunity; international cooperation; longitudinal human study; male; male reproductive system surgery; pathologic process; penis disorder; polymerase chain reaction; questionnaires; rectum neoplasms; sex behavior; sexually transmitted diseases; tissue resource /registry; urinalysis; virus infection mechanism; virus load

DESCRIPTION (provided by applicant): Human papillomavirus (HPV), a sexually transmitted infection, is strongly associated with invasive cervical, vulvar, and anal cancers in women, and penile and anal cancers in men. Internationally, the incidence of cervical cancer varies greatly, with high rates observed in Mexico and low rates observed in the US and Europe. In the US, Hispanic women have significantly elevated rates of disease compared with non-Hispanic whites. The sexual behavior of the male partner may be as or more important than a Hispanic or Mexican woman's personal sexual behavior in predicting her risk of HPV infection and cervical disease. Unfortunately, little is known regarding the prevalence, incidence, and clearance of HPV infections in men, hampering efforts to control infection in both men and women. We propose to conduct a large binational (US-Mexico) prospective study of men, the HPV in Men Study (HIM). The goal of this revised application is to further our understanding of the natural history of HPV infection in men so that effective programs can be developed to reduce HPV disease burden in both men and women. Specifically, our aims are to enroll a cohort of 3000 men who will be examined every six months for four years, determine the incidence and persistence of type-specific penile HPV infections, the humoral immune response to HPV infection, and assess the factors independently associated with acquisition, persistence, and clearance of type-specific HPV infections in men. We hypothesize that HPV infection type distribution in men differs by country, that most infections in men are transient, and that type-specific HPV antibody response occurs only among persistently positive men. In addition, we hypothesize that current condom use and circumcision confers reduced risk of incident HPV infection, and that other sexually acquired infections increase risk. Our proposed study is unique in that it will prospectively assess HPV infection in a large cohort of men in the US and Mexico, representing countries of high and low risk. The study is timely in that it will yield information on types of male infection and incidence of infection necessary to design vaccine efficacy studies in men. It is cost-effective, operating in Mexico with a significantly reduced cost per participant enrolled compared to the US, enrolling men representative of both countries, and partnering with industry to significantly reduce HPV genotyping costs.

描述（由申请人提供）： 人乳头瘤病毒（HPV）是一种性传播感染，与女性的浸润性宫颈癌、外阴癌和肛门癌以及男性的阴茎癌和肛门癌密切相关。在国际上，宫颈癌的发病率差异很大，在墨西哥观察到高发病率，在美国和欧洲观察到低发病率。在美国，西班牙裔女性的患病率明显高于非西班牙裔白人。男性伴侣的性行为在预测HPV感染和宫颈疾病的风险方面可能与西班牙裔或墨西哥女性的个人性行为一样重要或更重要。不幸的是，人们对男性HPV感染的患病率、发病率和清除率知之甚少，这阻碍了控制男性和女性感染的努力。我们建议进行一项大型的两国（美国-墨西哥）男性前瞻性研究，即男性HPV研究（HIM）。这项修订申请的目的是进一步了解男性HPV感染的自然史，以便制定有效的计划来减少男性和女性的HPV疾病负担。具体来说，我们的目标是招募一个3000名男性的队列，他们将每六个月进行一次检查，持续四年，确定类型特异性阴茎HPV感染的发生率和持续性，对HPV感染的体液免疫反应，并评估与男性类型特异性HPV感染的获得，持续性和清除独立相关的因素。我们假设男性HPV感染类型分布因国家而异，大多数男性感染是短暂的，并且类型特异性HPV抗体反应仅发生在持续阳性的男性中。此外，我们假设目前使用避孕套和包皮环切术可降低HPV感染的风险，而其他性获得性感染则会增加风险。我们提出的研究是独一无二的，因为它将前瞻性地评估美国和墨西哥（代表高风险和低风险国家）一大批男性的HPV感染。这项研究是及时的，因为它将产生关于男性感染类型和感染发生率的信息，这些信息是设计男性疫苗效力研究所必需的。它具有成本效益，在墨西哥运营，与美国相比，每位参与者的成本显着降低，招募两国的男性代表，并与行业合作，显着降低HPV基因分型成本。