Clinical Trials Program

该提案的总体目标是推进HPV相关癌症的预防干预 在拉丁美洲和加勒比地区（LAC）的男性和女性艾滋病毒感染者中发生。我们专注 预防两种HPV相关癌症，口咽癌和宫颈癌。两种癌症都是 与艾滋病毒阴性人群相比，艾滋病毒感染者的感染率显著升高， 预防、筛查和治疗挑战需要新的解决方案。 为了解决这些重大的公共卫生问题，我们将进行以下临床试验： 1.研究持续性口腔HPV感染的免疫预防，预防HPV相关OPC的替代方法，通过对9价 巴西、墨西哥和波多黎各男性艾滋病毒感染者接种HPV疫苗 2. HPV/宿主DNA甲基化分诊评估和优化宫颈癌HPV初筛 艾滋病毒感染妇女的癌症筛查 3.通过评估HPV相关宫颈癌前病变的治疗效果， 新型HPV治疗性疫苗PDS 0101的安全性、免疫原性和初步疗效 被诊断为宫颈HSIL的艾滋病毒感染妇女

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