HPV Vaccine for Anal Cancer Prevention
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on cART (HIV treatment), you must be on a stable regimen for at least six months.
What data supports the effectiveness of the 9-valent HPV vaccine treatment for preventing anal cancer?
Research shows that HPV vaccines, including the 9-valent type, are effective in preventing anal HPV infections and related precancerous lesions, which are linked to anal cancer. The 9-valent vaccine covers HPV types found in most anal cancers, suggesting it should effectively prevent anal cancer when given before sexual activity begins.12345
Is the 9-valent HPV vaccine safe for humans?
How is the 9-valent HPV vaccine unique for preventing anal cancer?
What is the purpose of this trial?
Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains, and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM.The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team was funded by the Canadian Institutes of Health Research (CIHR) via its Boys' and Men's Health Team Grant Competition. It aims to recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build large-scale screening and treatment trials on a national level. A key part of this research program involves an analysis of the potential role played by the HPV vaccine in the overall management of HIV-positive MSM.Planned vaccine-related projects include:* A mixed-methods analysis of the knowledge, attitudes, and acceptability of HPV vaccination amongst HIV-positive MSM, through quantitative (e.g. cross-sectional survey) and qualitative (e.g. in-depth interviews) means.* A comprehensive assessment of the 9-valent HPV vaccine in HIV-positive MSM, including safety and immunogenicity, as well as its potential role in secondary prevention of high-grade anal dysplasia. This is the study on which the current proposal is based.
Research Team
Irving Salit, MD
Principal Investigator
Toronto General Hospital, University Health Network
Eligibility Criteria
This trial is for HIV-positive men who have had sexual activity with men or both genders, are at least 18 years old, and have high-grade anal dysplasia (AIN-2 or -3). They must be willing to undergo standard ablative therapy and either be on a stable antiretroviral regimen or not planning to start one within six months. Participants need documented HIV infection and the ability to attend all study visits.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immediate Vaccination
Administration of dose #1 of 9-valent HPV vaccination at baseline visit, dose #2 at month 2, and dose #3 at month 6
Delayed Vaccination
Administration of dose #1 of 9-valent HPV vaccination at month 12, dose #2 at month 14, and dose #3 at month 18
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in anal carriage of vaccine HPV types and immunogenicity
Treatment Details
Interventions
- 9-valent HPV vaccination
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University