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Principal Investigator: TIMOTHY J. WILKIN
Organization: WEILL MEDICAL COLL OF CORNELL UNIV
Fiscal Year: 2020
Award: $1,017,165
Funding agency: National Cancer Institute
Clinical Trials Program Project Summary/Abstract
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 HPV-
associated 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
Terms: <AIDS Virus><Abscission><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Adolescent><Adolescent Youth><Affect><Age><Anal Cancer><Anal Cancers><Anus Cancer><Brazil><Cancer Cause><Cancer Etiology><Cancers><Caribbean><Caribbean Sea Region><Caribbean region><Cervical><Cervical Cancer><Cervical Cancer Screening><Cervix Cancer><Clinical Trials><Colposcopy><Cytology><DNA Methylation><Diagnosis><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Effectiveness><Excision><Extirpation><Failure><Female><Gender><Goals><HIV><HIV Seronegativities><HIV Seronegativity><HIV diagnosis><HIV negative><HPV><HPV 16><HPV Vaccination><HPV Vaccine><HPV infection><HPV-16><HPV-High Risk><HPV-Related Malignancy><HPV-associated cancer><HPV-associated malignancy><HPV-related cancer><HPV16><HTLV-III Seronegativities><HTLV-III Seronegativity><Health Care Systems><Healthcare Systems><High Prevalence><High Risk Oncogenic HPV><High risk HPV><High risk Human Papillomavirus><High risk Human papilloma virus><Human Immunodeficiency Viruses><Human Papilloma Virus><Human Papilloma Virus Vaccination><Human Papilloma Virus Vaccine><Human Papilloma Virus-Related Malignancy><Human Papilloma Virus-Related Malignant Neoplasm><Human Papilloma Virus-associated cancer><Human Papilloma Virus-associated malignancy><Human Papilloma Virus-related cancer><Human Papillomavirus><Human Papillomavirus Vaccination><Human papilloma virus infection><Human papilloma virus type 16><Human papillomavirus 16><Human papillomavirus Vaccine><Human papillomavirus infection><Human papillomavirus type 16><Human papillomavirus-Related Malignancy><Human papillomavirus-Related Malignant Neoplasm><Immune><Immunes><Incidence><Individual><Infectious Human Wart Virus><LAV-HTLV-III><Laboratories><Latin America><Lesion><Lymphadenopathy-Associated Virus><MSM><Malignant Anal Neoplasm><Malignant Anal Tumor><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Neoplasm of the Cervix><Malignant Neoplasms><Malignant Oropharyngeal Neoplasm><Malignant Oropharyngeal Tumor><Malignant Tumor><Malignant Tumor of the Anus><Malignant Tumor of the Cervix><Malignant Tumor of the Cervix Uteri><Malignant Uterine Cervix Neoplasm><Malignant Uterine Cervix Tumor><Malignant neoplasm of anus><Malignant neoplasm of cervix uteri><Methods><Mexico><Modality><Oropharnyx Cancers><Oropharyngeal Cancer><Oropharyngeal Carcinoma><Oropharynx Cancer><Oropharynx Carcinoma><Pathology><Peptides><Population><Preventative intervention><Preventative strategy><Prevention><Prevention intervention><Prevention program><Prevention strategy><Preventive Intervention><Preventive strategy><Primary Cancer Prevention><Primary Lesion><Primary Prevention><Process><Property><Public Health><Puerto Rico><Removal><Research><Research Resources><Resources><Safety><Specificity><Squamous Cell Intraepithelial Neoplasia><Squamous intraepithelial lesion><Surgical Removal><Testing><Triage><Uterine Cervix Cancer><Vaccinated><Vaccines><Virus-HIV><West Indies Region><Woman><ages><base><cervical cancer early detection><cervical cancer prevention><human papilloma virus 16><human papillomavirus associated malignancy><human papillomavirus-associated cancer><human papillomavirus-related cancer><immunogenicity><improved><juvenile><juvenile human><lipid nanoparticle><male><malignancy><malignant oropharynx neoplasm><malignant oropharynx tumor><men><men who have sex with men><men who have sex with other men><men's><mortality><neoplasm/cancer><neutralizing vaccine><new drug treatments><new drugs><new therapeutics><new therapy><next generation therapeutics><novel><novel drug treatments><novel drugs><novel therapeutics><novel therapy><oral HPV infection><oral human papilloma virus infection><oral human papillomavirus infection><performance tests><point of care><precancerous><premalignant><prevent><preventing><preventional intervention strategy><programs><randomized placebo controlled trial><resection><response><screening><screening program><therapeutic HPV vaccine><type 16 Human papilloma virus><type 16 Human papillomavirus><wart virus>