Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise

NCT ID: NCT01988948

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Infection by Human Papilloma Virus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

student cohort

Various biological sampling

• blood sampling,
• oral, vulvar, vaginal and anal sampling for women,
• oral and genital sampling for men

Group Type: OTHER

Various biological sampling

Intervention Type: OTHER

Interventions

Various biological sampling

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• voluntary student consulting the health service of university
• age 18-20 y.o.
• informed consent signed
• affiliated to national health insurance

• 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

• pregnancy
• end of the pregnancy within the last 3 months
• Student participating in another clinical trial

Men

none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Versailles Saint-Quentin-en-Yvelines University

OTHER

Sponsor Role: collaborator

centre national de référence pour les Papillomavirus Humains

UNKNOWN

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Guillemot, Pr, MD

Role: STUDY_DIRECTOR

Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERM

Elisabeth Delarocque-Astagneau, MD

Role: STUDY_DIRECTOR

Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / Inserm

Emmanuelle Mathiot-Vicaigne, MD

Role: PRINCIPAL_INVESTIGATOR

Versailles Saint-Quentin-en-Yvelines University

Locations

Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)

Versailles, , France

Countries

France

Other Identifiers

2012-A00814-39

Identifier Type: OTHER

Identifier Source: secondary_id

2011-42

Identifier Type: -

Identifier Source: org_study_id