HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
Infection by certain high-risk oncogenic types of Human Papillomavirus (HR-HPV) is the major
cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal.
Rates of high-grade anal dysplasia and anal cancer are much higher in men who have sex with
men (MSM) than in the general population. Rates of anal SCC in HIV-positive MSM are higher
than the historic rates of cervical cancer prior to the adoption of routine cervical cytology
screening. Despite these statistics, there are no established protocols for optimal screening
and treatment of anal cancer precursors. Further, there is growing evidence that HPV may
enhance sexual transmission of HIV. These significant knowledge gaps translate into
fundamental deficiencies in the care for HIV-positive MSM.
The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team aims to recruit a large
group of MSM from various Ontario and Vancouver clinics in order to carry out 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) 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
b) 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 upon which the current proposal is based.