Cervical, Anal, and Oral HPV Persistence and Risk Factors Among Adolescent Girls

青春期女孩的宫颈、肛门和口腔 HPV 持续性和危险因素

• 批准号: 8052929
• 负责人: ANGELA DIAZ
• 金额: $ 81.06万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-15 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8052929
• 关键词: 19 year old; Accounting; Address; Adolescence; Adolescent; Adolescent Medicine; African American; Age; Antibodies; Anus; Behavioral; Caring; Cervical; Cervix Uteri; Characteristics; Chlamydia; Clinic; Clinical; Clinical Trials; Coitus; Collection; Contraceptive Usage; DNA; Data; Data Reporting; Detection; Development; Disease; Dose; Effectiveness; Enrollment; Exposure to; Female Adolescents; Gardasil; Gonorrhea; Health; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Human papillomavirus 6; Immunization; Incidence; Incidence Study; Infection; Interview; Latino; Malignant neoplasm of anus; Measurement; Mucous Membrane; Neighborhoods; New York City; Oral; Oral cavity; Oral mucous membrane structure; Pap smear; Phase; Physicians; Pilot Projects; Population; Prevalence; Publishing; Recording of previous events; Reporting; Research; Research Design; Research Personnel; Risk Factors; Serum; Sex Behavior; Sexually Transmitted Diseases; Site; Smoking; Specimen; Structure; Substance abuse problem; Teenagers; Testing; Tissues; Tonsillar Neoplasms; Uncertainty; Vaccinated; Vaccination; Vaccines; Viral Load result; Virus-like particle; Visit; Woman; base; cervical and anal cancer; cohort; college; falls; high risk; inner city; malignant mouth neoplasm; novel vaccines; oral infection; pediatrician; prevent; programs; prospective; sexually active; tongue root; vaccine effectiveness; young adult

DESCRIPTION (provided by applicant): Human papillomavirus (HPV) infection is the central etiologic factor in the development of cervical and anal cancers. Recent data suggest that it is causally involved in 30 percent of oral cancers. Studies by our group and others have shown that 30-60 percent of sexually active college age women have cervical HPV infection. Our inner-city adolescence population, with its many high risk (HR) characteristics, has a prevalence of 63 percent cervical, 58 percent anal and 13 percent oral in our pilot study. The new Gardasil vaccine contains HPV 6, 11, 16 & 18 virus-like particles and has been shown to have a very high efficacy in HPV-DNA negative and HPV seronegative subjects. Little is know about its efficacy and effectiveness in a HR adolescent population, or in anal and oral mucosa. Despite these uncertainties physicians would find it unacceptable to not vaccinate high-risk adolescents, such as our population. The results of our research may demonstrate the need for a formal clinical trial of high risk adolescents. We therefore propose to study incidence of HPV infection following Gardasil vaccination in a prospective cohort of 1000 sexually active adolescent girls, ages 12-19 enrolled at the Mount Sinai AHC. We will collect baseline cervical, anal, oral specimens for HPV DNA testing and serum for HPV antibodies, the vaccine naive subjects will complete the 3 necessary vaccinations. They will be followed every 6 months for two years. Serum will be collected at baseline and 12 months. Our aims are to: 1) study the type-specific prevalence of HPV DNA in the cervix, anus, and oral cavity in high risk adolescents prior to vaccination including risk factors and co infection across sites; 2)determine the incidence of persistent HPV infection of the cervix following vaccination and contrast these rates with those expected based on the published vaccine trial results, by assessing incidence of persistent cervical infection in those adolescent women; 3)identify risk factors for an incidently developed persistent cervical infection with HPV, despite vaccination in those who were serologically and DNA negative for those types at baseline including infection in the anus or oral cavity and other risk factors; 4)study the incidence of persistent anal and oral infection with HPV following vaccination in this high risk cohort and the risk factors for infection with these HPV types in the anus, and to determine the incidence and risk factors for infection with phylogenetically- related and -unrelated HPV types in the anal and oral mucosa.

描述（由申请人提供）：人乳头瘤病毒（HPV）感染是宫颈和肛门癌发展的核心病因因素。最近的数据表明，它与30％的口服癌症有关。我们小组和其他人的研究表明，有30％至60％的性活跃大学妇女患有宫颈HPV感染。在我们的试点研究中，我们的城市青春期人口具有许多高风险（HR）特征，其患病率为63％，肛门58％，口服13％。新的Gardasil疫苗包含HPV 6、11、16和18个病毒样颗粒，并已被证明在HPV-DNA阴性和HPV血清负责受试者中具有很高的疗效。几乎不了解其在人力资源青春期或肛门和口服粘膜中的功效和有效性。尽管这些不确定性，医生会发现不接种高危青少年（例如我们的人口）是不可接受的。我们的研究结果可能表明需要对高风险青少年进行正式的临床试验。因此，我们建议在Gardasil疫苗接种后研究HPV感染的发生率，这是一名前瞻性队列的1000个性活跃的青春期女孩，年龄在Sinai AHC山中为12-19岁。我们将收集用于HPV DNA测试的基线宫颈，肛门，口服标本，以及用于HPV抗体的血清，疫苗天真的受试者将完成3种必要的疫苗接种。他们将每6个月每6个月遵循两年。血清将在基线和12个月内收集。我们的目的是：1）研究疫苗接种前高风险青少年中子宫颈，肛门和口腔中HPV DNA的特定类型患病率，包括跨部位的风险因素和CO感染； 2）通过评估那些青少年妇女的持续性宫颈感染的发生率，确定疫苗接种后持续的HPV感染宫颈感染的发生率，并将这些率与基于已发表的疫苗试验结果预期的速率进行对比； 3）确定患有HPV的持续发展的持续性宫颈感染的危险因素，尽管在血清学上的疫苗接种且DNA在基线时为DNA阴性，包括肛门或口腔或口腔中的感染以及其他危险因素； 4）研究该高风险队列中疫苗接种后持续的肛门和口腔感染的发生率以及肛门中这些HPV类型的感染风险因素，并确定肛门和口腔Mucosa中与系统发育相关的HPV类型的发病率和风险因素。