Clinical Trials Program

临床试验计划

• 批准号: 10706303
• 负责人: TIMOTHY J. WILKIN
• 金额: $ 95.44万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706303
• 关键词: Address; Adolescent; Affect; Age; Brazil; Cancer Etiology; Caribbean region; Cervical; Cervical Cancer Screening; Clinical Trials; Collaborations; Colposcopy; Conduct Clinical Trials; Cytology; DNA Methylation; Diagnosis; Double-Blind Method; Effectiveness; Excision; Failure; Female; Gender; Goals; HIV; HIV Seronegativity; HIV diagnosis; HPV oropharyngeal cancer; HPV-High Risk; Healthcare Systems; High Prevalence; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Immune; Immunoprevention; Incidence; Individual; Laboratories; Latin America; Learning; Lesion; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Methods; Mexico; Modality; Pathology; Peptides; Persons; Population; Prevention; Prevention program; Prevention strategy; Primary Cancer Prevention; Primary Lesion; Primary Prevention; Process; Property; Public Health; Puerto Rico; Research; Research Personnel; Resources; Safety; Site; Specificity; Squamous intraepithelial lesion; Testing; Triage; Vaccinated; Vaccines; Woman; cervical cancer prevention; experience; immunogenicity; improved; lipid nanoparticle; male; malignant oropharynx neoplasm; men; men who have sex with men; mortality; novel; novel therapeutics; oral HPV infection; performance tests; premalignant; prevent; preventive intervention; programs; randomized placebo controlled trial; response; screening; screening program; therapeutic HPV vaccine; vaccine strategy

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

该提案的总体目标是推进hpv相关癌症的预防干预措施