Infection by Human Papilloma Virus Clinical Trial
— DyPAVIROfficial title:
Impact de la Vaccination Sur la Distribution Des génotypes de Papillomavirus (HPV) et Suivi de la Dynamique Intra-individuelle de l'Infection et Des Co-infections Dans Une Population d'étudiantes âgées de 18 à 20 Ans
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 20 Years |
| Eligibility |
Women Inclusion Criteria: - voluntary student consulting the health service of university - age 18-20 y.o. - informed consent signed - affiliated to national health insurance Exclusion Criteria: - pregnancy - end of the pregnancy within the last 3 months - Student participating in another clinical trial Men Inclusion Criteria: - being the sexual partner of a woman included in this study - at least 18 y.o - informed consent signed - affiliated to national health insurance Exclusion Criteria: |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS) | Versailles |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Pasteur | centre national de référence pour les Papillomavirus Humains, German Cancer Research Center, Université de Versailles Saint-Quentin-en-Yvelines |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Factors associated with HPV infection and co-infection | 5 years | No | |
| Other | HPV clearance (all genotypes and genotype-specific HPV) | 5 years | No | |
| Primary | Proportion of HPV detection at inclusion (all HPV genotypes) | 2 years | No | |
| Secondary | Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes | 5 years | No |