CAMPO Clinical Trials Program

CAMPO 临床试验计划

基本信息

批准号：
10226225
负责人：
JOEL Michael PALEFSKY
金额：
$ 85.06万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
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：
2019-09-12 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10226225
关键词：
Adenoviruses Age Algorithms Anus CD8B1 gene California Caribbean region Cervical Clinical Research Clinical Trials Cytology DNA Detection Disease Genotype HIV HIV Seropositivity HPV-High Risk Health Benefit Healthcare Hispanics Human Papilloma Virus Vaccine Human Papilloma Virus-Related Malignant Neoplasm Human Papillomavirus Human papilloma virus infection Immune Immune response Incidence Individual Infection Latin America Lesion Mediating Methylation Mexican Mexico Oncoproteins Outcome Performance Placebos Population Predictive Value Prevention Probiotics Proteins Protocols documentation Puerto Rican Puerto Rico Quality of life Recommendation Research Research Personnel Resources Risk Safety Sensitivity and Specificity Site Squamous intraepithelial lesion T-Lymphocyte Testing Viral Viral Markers Viral Physiology Woman base cancer therapy cervical and anal cancer cervical cancer prevention cost effective cost effectiveness design improved innovation interest men methylation biomarker microbiome microbiome alteration microbiota microbiota profiles mortality novel novel strategies novel therapeutics programs protein expression recruit research study safety testing screening secondary endpoint therapeutic HPV vaccine therapeutic vaccine

项目摘要

ABSTRACT OF THE CLINICAL TRIALS PROGRAM The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV- positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. The CAMPO Clinical Trials Program has the following aims: (1) To identify optimal screening strategies among HIV-positive women in Mexico and Puerto Rico for cervical HSIL detection, including cytology, HPV extended-typing, oncoprotein E6/E7 testing and methylation markers; (2) To determine the safety and efficacy of Visbiome™ probiotic on cervical and anal HSIL regression and reduced persistence of high-risk HPV infection in HIV-positive women and men in Mexico and Puerto Rico; and (3) To determine the safety and efficacy of a novel therapeutic vaccine on cervical and anal HSIL regression in HIV-positive women and men in Mexico and Puerto Rico. The Clinical Trials Program will be led by Dr. Joel Palefsky (Contact MPI) and co-led by Dr. Jorge Salmerón (MPI) of the INSP. The Protocol Chairs of the three studies are Dr. Jorge Salmerón (Study 1), Dr. Josefina Romaguera of UPR (Study 2), and Dr. George Sawaya of UCSF (Study 3). Protocol Teams for each study will be comprised of the Protocol Chair, representatives of each CAMPO Core, a representative from Emmes, and investigators from all three sites with relevant expertise and interest. Each of the studies is highly innovative. Study 1 uses new approaches for recruitment and performance of cervical screening in HIV-positive women and will include cost-effectiveness and quality of life analyses. Study 2 will test the safety of a probiotic for treatment of HSIL in HIV-positive women and men and its ability to reduce the risk of persistent hrHPV infection among those without disease. Study 3 will test a novel therapeutic vaccine for treatment of HSIL that covers multiple hrHPV types and HPV proteins. We expect the results of the three studies to change the paradigm of both screening and treatment of HSIL, with the potential to substantially reduce the incidence of cervical and anal cancers in HIV-positive women and men in Mexico and Puerto Rico. Our results will be broadly applicable to other populations in the Latin America and Caribbean region, and to a large extent, to Hispanic and other women in the U.S.

临床试验计划摘要加州-墨西哥-波多黎各 (CAMPO) 联盟将进行三项临床研究研究 1 的重点是预防墨西哥和波多黎各艾滋病毒阳性妇女的宫颈癌。将在 4000 年检查宫颈高级鳞状上皮内病变 (HSIL) 的新筛查算法墨西哥和波多黎各的艾滋病毒阳性女性研究 2 将评估使用肛门生殖器益生菌对健康的影响。 600 例 HIV 感染者的肛门和宫颈微生物群特征及其与肛门和宫颈 HSIL 回归的关系女性和男性呈阳性，以及无病变人群中高危 HPV DNA 持久性降低。研究 3 将评估基于多价复制缺陷型腺病毒的安全性和有效性 HPV 疫苗可治疗 300 名 HIV 阳性女性和男性的宫颈和治疗性肛门 HSIL，并确定免疫反应与 HSIL 消退相关。 CAMPO 临床试验计划的目标如下： (1) 确定墨西哥和波多黎各艾滋病毒阳性女性宫颈癌的最佳筛查策略 HSIL检测，包括细胞学、HPV延伸分型、癌蛋白E6/E7检测和甲基化标志物； (2) 确定 Visbiome™ 益生菌对宫颈和肛门 HSIL 消退的安全性和有效性，以及墨西哥和波多黎各艾滋病毒阳性女性和男性的高危 HPV 感染持续率降低； (3) 确定新型治疗性疫苗对宫颈和肛门 HSIL 消退的安全性和有效性墨西哥和波多黎各的艾滋病毒阳性女性和男性临床试验项目将由乔尔博士领导。 Palefsky（联系 MPI），由 INSP 的 Jorge Salmerón 博士（MPI）共同领导。研究人员包括 Jorge Salmerón 博士（研究 1）、UPR 的 Josefina Romaguera 博士（研究 2）和 George Sawaya 博士 UCSF（研究 3）的方案小组将由方案主席、代表组成。每个 CAMPO 核心、Emmes 的代表以及来自所有三个站点的具有相关专业知识的调查人员每项研究都具有高度创新性。研究 1 使用了新的招募和兴趣方法。 HIV 阳性女性宫颈筛查的表现，包括成本效益和生活质量研究 2 将测试益生菌治疗 HIV 阳性女性和男性 HSIL 的安全性。研究 3 将测试一种新的方法，以降低未患病者持续感染 hrHPV 的风险。我们期待用于治疗 HSIL 的治疗性疫苗，涵盖多种 hrHPV 类型和 HPV 蛋白。这三项研究的结果改变了 HSIL 筛查和治疗的范式，具有潜在的潜力大幅降低墨西哥艾滋病毒阳性女性和男性的宫颈癌和肛门癌发病率我们的结果将广泛适用于拉丁美洲和加勒比地区的其他人群。地区，并在很大程度上，影响到美国的西班牙裔和其他女性