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

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.

Study Overview

• Status: Completed
• Conditions: Infection by Human Papilloma Virus
• Intervention / Treatment: Other: Various biological sampling

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Versailles, France, 78000
    • Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 20 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: student cohort; Various biological sampling; blood sampling,; oral, vulvar, vaginal and anal sampling for women,; oral and genital sampling for men	Other: Various biological sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of HPV detection at inclusion (all HPV genotypes)	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes	5 years

Other Outcome Measures

Outcome Measure	Time Frame
Factors associated with HPV infection and co-infection	5 years
HPV clearance (all genotypes and genotype-specific HPV)	5 years

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: German Cancer Research Center; Versailles Saint-Quentin-en-Yvelines University; centre national de référence pour les Papillomavirus Humains
• Investigators: Study Director: Didier Guillemot, Pr, MD, Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERM; Study Director: Elisabeth Delarocque-Astagneau, MD, Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / Inserm; Principal Investigator: Emmanuelle Mathiot-Vicaigne, MD, Versailles Saint-Quentin-en-Yvelines University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Human papilloma virus; Young women; I-Share
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Infections; Papilloma
• Other Study ID Numbers: 2011-42; 2012-A00814-39 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED