An interventional study of Various biological sampling in Infection by Human Papilloma Virus, sponsored by Institut Pasteur. Completed at 1 site in France. Open to participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Basic science
Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The introduction of vaccination against two major oncogenic genotypes of HPV raises questions about genotype replacement because of the existence of other oncogenic types not targeted by the vaccine. A better understanding of natural history of HPV infection and interaction (competition, synergy) between genotypes are required in order to anticipate this phenomenon.
The aims of this study are to characterize HPV infection in young female students and to follow up HPV infection and co-infection dynamics with different genotypes, taking into account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the determination of factors influencing the development of persistent cervical HPV infections.
The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18 to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire regarding sexual behaviour, socio-demographic characteristics, access to health-care services and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to test feasibility.
This study will provide data to gain insight into the possibility of type replacement. Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV incidence and factors associated with HPV infection and co-infection ; Partners recruitment would allow us to follow HPV transmission dynamics among couples, and in particular, HPV exposure in young adult women. The HPV research won't be limited to virus detection in samples but will indicate the presence or absence of HPV infection.
Finally, additional genetic studies could be conducted in order to study genetic susceptibility to HPV infection, to chronic HPV infection and to co-infection.
This research project is part of the i-Share program funded by the "Investissement d'Avenir" cohort call.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 49 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Institut Pasteur is the lead sponsor of 96 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women
Inclusion Criteria:
Exclusion Criteria:
Men
Inclusion Criteria:
Exclusion Criteria:
none
Various biological sampling * blood sampling, * oral, vulvar, vaginal and anal sampling for women, * oral and genital sampling for men
Other: Various biological sampling
Proportion of HPV detection at inclusion (all HPV genotypes)
Time frame: 2 years
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
Time frame: 5 years
Factors associated with HPV infection and co-infection
Time frame: 5 years
HPV clearance (all genotypes and genotype-specific HPV)
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Pasteur