CAMPO Clinical Trials Program

CAMPO 临床试验计划

• 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
• 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

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.

临床试验摘要 加利福尼亚-墨西哥-波多黎各（CAMPO）联盟将进行三项临床研究 重点是在墨西哥和波多黎各预防艾滋病毒阳性妇女的宫颈癌。研究1 将在4000年检查宫颈高度鳞状上皮内病变（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将评估肛门生殖器益生菌使用对 肛门和宫颈微生物群特征以及与600例HIV感染者肛门和宫颈HSIL消退的关系- 阳性的女性和男性以及没有病变的人中高危HPV DNA持续性的降低。 研究3将评估多价复制缺陷型腺病毒为基础的安全性和有效性。 治疗性HPV疫苗治疗300名HIV阳性女性和男性的宫颈和肛门HSIL， 免疫应答与HSIL消退相关。CAMPO临床试验计划有以下目标： (1)确定墨西哥和波多黎各艾滋病毒阳性妇女宫颈癌的最佳筛查策略， HSIL检测，包括细胞学、HPV扩展分型、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， 降低墨西哥和波多黎各艾滋病毒阳性妇女和男子中高危HPV感染的持续性;以及 (3)确定一种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妇女和男子。临床试验项目将由Joel博士领导 Palefsky（MPI联系人）和由INSP的Jorge Salmerón博士（MPI）共同领导。 Jorge Salmerón博士（研究1）、普遍定期审议的Josefina Romaguera博士（研究2）和乔治萨瓦亚博士（研究3） UCSF（研究3）。每项研究的方案小组将由方案主席、 每个CAMPO核心，一名来自Emmes的代表，以及来自所有三个研究中心的具有相关专业知识的研究人员 和兴趣。每一项研究都极具创新性。研究1采用新的招募方法， 对艾滋病毒抗体阳性妇女进行子宫颈检查，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阳性女性和男性HSIL的安全性， 它能够降低无疾病人群中持续性hrHPV感染的风险。研究3将测试一部小说 用于治疗HSIL的治疗性疫苗，其涵盖多种hrHPV类型和HPV蛋白。我们预计 这三项研究的结果改变了HSIL筛查和治疗的模式， 大幅度降低墨西哥艾滋病毒阳性妇女和男子的宫颈癌和肛门癌发病率 和波多黎各。我们的研究结果将广泛适用于拉丁美洲和加勒比地区的其他人群 在很大程度上，对西班牙裔和美国其他女性来说，