Author: Don Ward Hackett, Fact checked by Robert Carlson, MD & Danielle Reiter, RN
Does the HPV vaccine protect against oral infections?
That’s the question a new National Cancer Institutes (NCI) funded clinical trial of the Gardasil 9 vaccine hopes to answer.
This extensive study will determine whether the Gardasil 9 vaccine can prevent persistent oral HPV infections among men who are Human Immunodeficiency Virus (HIV) positive, said the NCI online on October 8, 2019.
Oral HPV infections and HPV-related oral cancers are common in men and among HIV-positive individuals.
Gardasil 9 is the most recent formulation of the Human Papolivirus (HPV) vaccine, which covers 5 additional cancer-causing HPV types. There are over 100 types of HPV.
“We are hoping that if we show the efficacy of the vaccine, that vaccinating both males and females will ultimately reverse” the rising incidence of HPV-related oropharyngeal cancers, said one of the trial’s lead investigators, Anna Giuliano, Ph.D., of Moffitt Cancer Center.
The trial is one of several within the US–Latin American–Caribbean Clinical Trials Network (ULACNet), an NCI-led effort to reduce the burden of HPV-related cancers in HIV-positive individuals.
This new study intends to build relevant insights upon a June 2017 study found that vaccination against HPV may sharply reduce oral HPV infections that are a major risk factor for oropharyngeal cancer, a type of head and neck cancer, says the NCI.
The 2017 study found that the prevalence of oral infection with 4 HPV types, including two high-risk, or cancer-causing, types, was 88 percent lower in those who reported receiving at least 1-dose of an HPV vaccine, than in those who said they were not vaccinated.
The ULACNet international collaborative research network brings together institutions in the United States and counterparts in low- and middle-income countries (LMICs) in the Latin American and the Caribbean (LAC) region.
Funded in Fall 2019 via a U54 Partnership Centers Cooperative Agreement mechanism, ULACNet comprises 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.
ULACNet investigators collaborate with the NCI to design and conduct clinical trials on three key scientific areas across the continuum of prevention interventions for HPV-related cancers in people living with HIV, including:
- optimizing dosing and delivery and evaluating new indications for HPV prophylactic vaccines
- evaluating new biomarkers and technologies for improving the accuracy of cervical and anogenital cancer screening and triage
- evaluating novel non-excisional treatments for HPV-related precancerous lesions
Outcomes of ULACNet clinical trials are expected to influence the development of clinical practice guidelines to improve preventive clinical care and reduce the burden of highly preventable HPV-related cancers in people living with HIV.
The three ULACNet Partnership Centers include the following collaborations between institutions in the United States and partners in Mexico, Puerto Rico, Brazil, Peru, and the Dominican Republic:
- 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).
For more information about this important clinical trial, please contact the ULACNet Program Director is Vikrant Sahasrabuddhe, MBBS, DrPH in the NCI Division of Cancer Prevention.
US-Latin American-Caribbean Clinical Trials Network (ULACNet) for Prevention of HPV-related Cancers in People Living with HIV
HPV Vaccine May Provide Men with “Herd Immunity” against Oral HPV Infections
HPV Vaccination Linked to Decreased Oral HPV Infections
HPV-Related Cancer Prevention and Control Programs at Community-Based HIV/AIDS Service Organizations: Implications for Future