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Completed

NCT Number: NCT01988948

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

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.

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Key information

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Versailles, 78000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Various biological sampling

Other

Primary outcomes

  1. Proportion of HPV detection at inclusion (all HPV genotypes)

    Time frame: 2 years

Secondary outcomes

  1. Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes

    Time frame: 5 years

Other outcomes

  1. Factors associated with HPV infection and co-infection

    Time frame: 5 years

  2. HPV clearance (all genotypes and genotype-specific HPV)

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • German Cancer Research Center
  • Versailles Saint-Quentin-en-Yvelines University
  • centre national de référence pour les Papillomavirus Humains

Registry information

Official study 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

Acronym: DyPAVIR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2013
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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