Clinical Trials Program

临床试验计划

基本信息

批准号：
10706303
负责人：
TIMOTHY J. WILKIN
金额：
$ 95.44万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-20 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10706303
关键词：
Address Adolescent Affect Age Brazil Cancer Etiology Caribbean region Cervical Cervical Cancer Screening Clinical Trials Collaborations Colposcopy Conduct Clinical Trials Cytology DNA Methylation Diagnosis Double-Blind Method Effectiveness Excision Failure Female Gender Goals HIV HIV Seronegativity HIV diagnosis HPV oropharyngeal cancer HPV-High Risk Healthcare Systems High Prevalence Human Papilloma Virus Vaccination Human Papilloma Virus Vaccine Human Papilloma Virus-Related Malignant Neoplasm Human Papillomavirus Human papilloma virus infection Human papillomavirus 16 Immune Immunoprevention Incidence Individual Laboratories Latin America Learning Lesion Malignant Neoplasms Malignant neoplasm of anus Malignant neoplasm of cervix uteri Methods Mexico Modality Pathology Peptides Persons Population Prevention Prevention program Prevention strategy Primary Cancer Prevention Primary Lesion Primary Prevention Process Property Public Health Puerto Rico Research Research Personnel Resources Safety Site Specificity Squamous intraepithelial lesion Testing Triage Vaccinated Vaccines Woman cervical cancer prevention experience immunogenicity improved lipid nanoparticle male malignant oropharynx neoplasm men men who have sex with men mortality novel novel therapeutics oral HPV infection performance tests premalignant prevent preventive intervention programs randomized placebo controlled trial response screening screening program therapeutic HPV vaccine vaccine strategy

项目摘要

The overall goal of the proposal is to advance prevention interventions for HPV-associated cancers occurring among men and women living with HIV in Latin America and the Caribbean (LAC). We are focusing on prevention of two HPV-associated cancers, oropharyngeal cancer and cervical cancer. Both cancers are significantly elevated among individuals living with HIV compared to HIV negative populations and present prevention, screening, and treatment challenges requiring new solutions. To address these significant public health concerns, we will perform the following clinical trials: 1. Investigate immunoprevention of persistent oral HPV infection, a surrogate for prevention of HPVassociated OPC, by conducting a double-blind, randomized, placebo-controlled trial of the 9-valent HPV vaccine among men living with HIV in Brazil, Mexico and Puerto Rico 2. Evaluate and optimize primary HPV screening with triage to HPV/host DNA methylation for cervical cancer screening among women living with HIV 3. Evaluate non-surgical approaches for treating HPV-related cervical pre-cancer by evaluating the safety, immunogenicity and preliminary efficacy of a novel HPV therapeutic vaccine, PDS0101, in women living with HIV diagnosed with cervical HSIL

该提案的总体目标是推进与HPV相关癌症的预防干预措施发生在拉丁美洲和加勒比海（LAC）的男性和妇女中。我们正在集中精力预防两种HPV相关的癌症，口咽癌和宫颈癌。两种癌症都是与艾滋病毒负面人群相比需要新解决方案的预防，筛查和治疗挑战。为了解决这些重要的公共卫生问题，我们将进行以下临床试验： 1。通过进行双盲，随机的，安慰剂对照试验的持续性口服HPV感染的免疫预防，以预防HPVASSIDEC的OPC。 HPV疫苗在巴西，墨西哥和波多黎各的男性中 2。评估和优化用分类筛选到HPV/宿主DNA甲基化的主要HPV筛选以进行宫颈艾滋病毒妇女的癌症筛查 3。评估非手术方法来通过评估与HPV相关的宫颈前疗法新型HPV治疗疫苗的安全性，免疫原性和初步功效，PDS0101 患有HIV的妇女被诊断为宫颈HSIL