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临床试验/NCT01988948
NCT01988948已完成不适用

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

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Proportion of HPV detection at inclusion (all HPV genotypes)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Proportion of HPV detection at inclusion (all HPV genotypes)

时间窗: 2 years

次要结局

  • Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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