Clinical Trials Program

该提案的总体目标是推进对HPV相关癌症的预防干预。 发生在拉丁美洲和加勒比(LAC)艾滋病毒携带者中。我们正在集中精力 关于预防两种与HPV相关的癌症，口咽癌和宫颈癌。两种癌症都是 与艾滋病毒阴性人群和现在相比，艾滋病毒携带者的比例显著上升 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.通过对9价HPV进行双盲、随机、安慰剂对照试验，研究持续口腔HPV感染的免疫预防，这是预防HPV相关OPC的替代品 巴西、墨西哥和波多黎各艾滋病毒携带者接种HPV疫苗 2.对宫颈HPV/宿主DNA甲基化的初步HPV筛查进行评估和优化 艾滋病病毒携带者妇女的癌症筛查 3.通过评估HPV相关宫颈癌前病变的非手术治疗方法来评估 新型HPV治疗性疫苗PDS0101的安全性、免疫原性和初步疗效 感染艾滋病毒的妇女被诊断为宫颈HSIL

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