CAMPO Clinical Trials Program

CAMPO 临床试验计划

• 批准号: 10469357
• 负责人: JOEL Michael PALEFSKY
• 金额: $ 83.5万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10469357
• 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; Hispanic; 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; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; 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 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

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 HIVpositive 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.

加利福尼亚 - 墨西哥 - 普洛托Rico（Campo）财团将进行三项临床研究 专注于预防墨西哥和波多黎各的HIV阳性女性宫颈癌。研究1 将检查4000中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妇女。研究2将评估肛门生物益生菌对 肛门和宫颈微生物群的谱以及与无病变患者的600名HIVPSISTIS效率男性和男性的肛门和宫颈HSIL回归的关系以及降低高风险HPV DNA持久性。 研究3将评估基于多价复制缺陷型腺病毒的安全性和效率 治疗性HPV疫苗可在300名HIV阳性男性和男性中治疗宫颈和肛门HSIL并鉴定 HSIL回归的免疫反应相关。 Campo临床试验计划具有以下目的： （1）确定墨西哥的HIV阳性妇女和波多黎各的最佳筛查策略 HSIL检测，包括细胞学，HPV扩展型，癌蛋白E6/E7测试和甲基化标记； （2）确定Visbiome™益生菌对宫颈和肛门HSIL回归的安全性和效率 在墨西哥和波多黎各的HIV阳性男性和男性中，高风险HPV感染的持久性降低；和 （3）确定新型热真空对宫颈和肛门HSIL回归的安全性和有效性 墨西哥和波多黎各的艾滋病毒阳性男女。临床试验计划将由乔尔博士领导 Palefsky（联系MPI），并由Insp的JorgeSalmerón博士（MPI）共同领导。三个协议椅 研究是JorgeSalmerón博士（研究1），UPR的Josefina Romaguera博士（研究2）和George Sawaya博士 UCSF（研究3）。每个研究的协议团队将完成协议主席，代表 每个Campo Core，来自Emmes的代表以及来自所有具有相关专业知识的三个站点的调查员 有趣。每项研究都是高度创新的。研究1使用新方法进行招聘和 在HIV阳性女性中进行宫颈筛查的表现，并将包括成本效益和生活质量 分析。研究2将测试益生菌治疗HIV阳性男性和男性HSIL的安全性 它有能力降低没有疾病患者中持续性HRHPV感染的风险。研究3将测试小说 用于治疗HSIL的治疗疫苗，涵盖了多种HRHPV类型和HPV蛋白。我们期望 这三项研究的结果是改变HSIL筛查和治疗的范式，潜力 大大降低墨西哥艾滋病毒阳性男女宫颈和肛门癌的发生率 和波多黎各。我们的结果将广泛适用于拉丁美洲和加勒比海地区的其他人群 在美国的地区，在很大程度上是美国和其他妇女