A new National Cancer Institute (NCI) funded clinical trial will help investigators determine whether a HPV Vaccine known as “Gardasil 9” can reduce oral cancer risks for HIV-positive men. The study team hopes to determine if the Gardasil 9 vaccine can prevent persistent oral HPV infections among HIV positive men.
What is Gardasil 9?
Follow up on 2017 Study
Investigators in this study hope to capitalize on insights and learnings from a study back in June 2017 which found that HPV vaccination may reduce oral HPV infections that pose substantial risk for oropharyngeal cancer, a type of head and neck cancer.
In this study, the team found that oral infection with 4 HPV types (including two high-risk/cancer causing types) was 88% reduced for those who received at least 1-dose of an HPV vaccine than in those who were not vaccinated.
The trial will be conducted by the NCI-led US-Latin American-Caribbean Clinical Trials Network (ULACNET). The network seeks to reduce the burden of HPV-related cancers in HIV-positive individuals. ULACNet, an international collaborative, represents institutions in the U.S. as well as countries across Latin America and the Caribbean region. Its investigators collaborate with the NCI to design and conduct studies with a focus on three scientific areas across the continuum of prevention interventions for HPV-related cancers in people living with HIV.
It consists of 3 Partnership Centers, each collaboratively conducting a multidisciplinary Clinical Trials Program supported via an infrastructure of an Administrative and Coordinating Core, a Data Management and Statistical Core and a Central Laboratory Core.
The three Partnership Centers include:
- University of California, San Francisco (UCSF) in San Francisco, CA (PI: Joel Palefsky, MD) in partnership with University of Puerto Rico in San Juan, Puerto Rico (PI: Anna Patricia Ortiz, PhD, MPH) and National Institute of Public Health (INSP) in Cuernavaca, Morelos, Mexico (PI: Jorge Salmeron, MD, DSc)
- Weill Medical College of Cornell University in New York, NY (PI: Timothy Wilkin, MD, MS) in partnership with Moffitt Cancer Center, in Tampa, FL (PI: Anna Giuliano, PhD, MPH), University of Sao Paulo in Sao Paulo, Brazil (PI: Luisa Villa, PhD), National Institute of Public Health (INSP) in Cuernavaca, Morelos, Mexico (PI: Eduardo Lazcano-Ponce, MD, PhD), and the University of Puerto Rico in San Juan, Puerto Rico (PI: Jorge Santana-Bagur, MD)
- Fred Hutchinson Cancer Research Center in Seattle, WA (PIs: Margaret Madeleine, PhD, MPH, and Ann Duerr, MD, PhD) in partnership with Asociacion Civil Via Libre in Lima, Peru (PI: Robinson Cabello, MD), National Institute of Infectious Diseases Evandro Chagas-Oswaldo Cruz Foundation (FIOCRUZ) in Rio de Janeiro, Brazil (PI: Beatriz Grinsztejn, MD, PhD), PATH in Seattle, WA (PI: Silvia de Sanjose, MD, PhD), and Instituto Dermatologico Dominicano y Cirugia de Piel (IDCP) in Santo Domingo, Dominican Republic (PI: Yeycy Donastorg, MD).