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Principal Investigator: TIMOTHY J. WILKIN
Organization: WEILL MEDICAL COLL OF CORNELL UNIV
Fiscal Year: 2023
Award: $954,399
Funding agency: National Cancer Institute
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
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><Collaborations><Colposcopy><Conduct Clinical Trials><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 + oropharyngeal carcinoma><HPV 16><HPV Vaccination><HPV Vaccine><HPV induced cancer><HPV infection><HPV malignancy><HPV mediated oropharynx cancer><HPV oropharyngeal cancer><HPV positive oropharyngeal cancer><HPV positive oropharynx cancer><HPV related oropharyngeal cancer><HPV related oropharyngeal carcinoma><HPV+ OPC><HPV+ cancer><HPV+ oropharyngeal cancer><HPV-16><HPV-High Risk><HPV-OPC><HPV-Related Malignancy><HPV-associated cancer><HPV-associated malignancy><HPV-associated oropharyngeal cancer><HPV-driven oropharyngeal cancer><HPV-related OPC><HPV-related cancer><HPV-related oropharyngeal 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 cancer><Human papillomavirus driven oropharyngeal cancer><Human papillomavirus induced cancer><Human papillomavirus infection><Human papillomavirus malignancy><Human papillomavirus related oropharyngeal carcinoma><Human papillomavirus type 16><Human papillomavirus- related oropharyngeal cancer><Human papillomavirus-Related Malignancy><Human papillomavirus-Related Malignant Neoplasm><Human papillomavirus-associated oropharyngeal cancer><Immune><Immunes><Immunoprevention><Incidence><Individual><Infectious Human Wart Virus><Investigators><LAV-HTLV-III><Laboratories><Latin America><Learning><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><Persons><Population><Preventative intervention><Preventative strategy><Prevention><Prevention program><Prevention strategy><Preventive strategy><Primary Cancer Prevention><Primary Lesion><Primary Prevention><Process><Property><Public Health><Puerto Rico><Removal><Research><Research Personnel><Research Resources><Researchers><Resources><Safety><Site><Specificity><Squamous Cell Intraepithelial Neoplasia><Squamous intraepithelial lesion><Surgical Removal><Testing><Triage><Uterine Cervix Cancer><Vaccinated><Vaccines><Virus-HIV><West Indies Region><Woman><ages><anal squamous cell carcinoma><cervical cancer early detection><cervical cancer prevention><cervical screening><experience><human papilloma virus 16><human papillomavirus associated malignancy><human papillomavirus mediated oropharynx cancer><human papillomavirus positive oropharyngeal cancer><human papillomavirus positive oropharyngeal carcinoma><human papillomavirus positive oropharynx carcinoma><human papillomavirus+ oropharyngeal cancer><human papillomavirus-associated cancer><human papillomavirus-related cancer><immunogenicity><improved><intervention for prevention><juvenile><juvenile human><lipid based nanoparticle><lipid nanoparticle><male><malignancy><malignant oropharynx neoplasm><malignant oropharynx tumor><men><men having sex with men><men who have sex with men><men who have sex with other men><mortality><neoplasm/cancer><new drug treatments><new drugs><new pharmacological therapeutic><new therapeutics><new therapy><next generation therapeutics><novel><novel drug treatments><novel drugs><novel pharmaco-therapeutic><novel pharmacological therapeutic><novel therapeutics><novel therapy><oral HPV infection><oral human papilloma virus infection><oral human papillomavirus infection><performance tests><precancer><precancer cervical detection><precancerous><premalignant><prevent><preventing><prevention intervention><preventional intervention strategy><preventive intervention><programs><randomized placebo control trial><randomized placebo controlled trial><resection><response><screening><screening program><screenings><therapeutic HPV vaccine><therapeutic human papillomavirus vaccine><type 16 Human papilloma virus><type 16 Human papillomavirus><vaccine strategy><wart virus>