Clinical Trials Program

该提案的总体目标是推进 HPV 相关癌症的预防干预措施 发生在拉丁美洲和加勒比海地区 (LAC) 的男性和女性艾滋病毒感染者中。我们正在专注 预防两种 HPV 相关癌症：口咽癌和宫颈癌。这两种癌症都是 与艾滋病毒阴性人群相比，艾滋病毒感染者的感染率显着升高，并且目前 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 价疫苗进行双盲、随机、安慰剂对照试验，研究持续性口腔 HPV 感染的免疫预防，这是预防 HPV 相关 OPC 的替代方法 巴西、墨西哥和波多黎各的艾滋病毒感染者接种 HPV 疫苗 2. 评估和优化初级 HPV 筛查，对宫颈癌的 HPV/宿主 DNA 甲基化进行分类 对感染艾滋病毒的女性进行癌症筛查 3. 通过评估治疗 HPV 相关宫颈癌前病变的非手术方法 新型 HPV 治疗性疫苗 PDS0101 的安全性、免疫原性和初步疗效 感染 HIV 的女性被诊断患有宫颈 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