Clinical trial NCT01988948: Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection by Human Papilloma Virus
Keywords: Human papilloma virus
Young women
I-Share
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Versailles Saint-Quentin-en-Yvelines University
name: centre national de référence pour les Papillomavirus Humains
name: German Cancer Research Center
First posted: 2013-11-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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:

none

Primary outcomes:
measure: Proportion of HPV detection at inclusion (all HPV genotypes)
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
timeFrame: 5 years
Other outcomes:
measure: Factors associated with HPV infection and co-infection
timeFrame: 5 years
measure: HPV clearance (all genotypes and genotype-specific HPV)
timeFrame: 5 years
Locations:
city: Versailles
country: France
facility: Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)
Study officials:
affiliation: Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERM
name: Didier Guillemot, Pr, MD
role: STUDY_DIRECTOR
affiliation: Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / Inserm
name: Elisabeth Delarocque-Astagneau, MD
role: STUDY_DIRECTOR
affiliation: Versailles Saint-Quentin-en-Yvelines University
name: Emmanuelle Mathiot-Vicaigne, MD
role: PRINCIPAL_INVESTIGATOR
References: