Infection by Human Papilloma VirusDyPAVIRNCT01988948
Dynamics of Human PApilloma Virus Interactions; Internet-based Students HeAlth Research Enterprise
A study testing Various biological sampling in people with Infection by Human Papilloma Virus, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection by Human Papilloma Virus
- What is being tested?
- Various biological sampling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- end of the pregnancy within the last 3 months
- Student participating in another clinical trial
- Men
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)
Versailles, 78000
About this study
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
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.
Read more
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
- Being tested
- Various biological sampling
- Keywords
- Human papilloma virus, Young women, I-Share
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various biological samplingOther
| Study group | Role | What they receive |
|---|---|---|
| student cohort | Other | Various biological sampling
* blood sampling,
* oral, vulvar, vaginal and anal sampling for women,
* oral and genital sampling for men Receives: Other: Various biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HPV detection at inclusion (all HPV genotypes)
Measured: 2 years
Secondary outcomes (1)
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection by Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Versailles Saint-Quentin-en-Yvelines University, centre national de référence pour les Papillomavirus Humains, German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Didier Guillemot, Pr, MD, Study director, Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERMElisabeth Delarocque-Astagneau, MD, Study director, Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / InsermEmmanuelle Mathiot-Vicaigne, MD, Principal investigator, Versailles Saint-Quentin-en-Yvelines University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988948
- Sponsor's protocol ID
- 2011-42
- Other IDs
- 2012-A00814-39
- Acronym
- DyPAVIR
- Status last verified
- Aug 2016
- First submitted
- 14 Nov 2013
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01988948
- Acronym / sponsor ID
- DyPAVIR / 2011-42
- Conditions
- Infection by Human Papilloma Virus
- Keywords
- Human papilloma virus, Young women, I-Share
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Versailles Saint-Quentin-en-Yvelines University, centre national de référence pour les Papillomavirus Humains, German Cancer Research Center
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| student cohort | Other | Other: Various biological samplingVarious biological sampling * blood sampling, * oral, vulvar, vaginal and anal sampling for women, * oral and genital sampling for men |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- pregnancy
- end of the pregnancy within the last 3 months
- Student participating in another clinical trial
- Men
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Various biological sampling | Other | student cohort |
Primary outcome
Proportion of HPV detection at inclusion (all HPV genotypes)
Time frame: 2 years
1 secondary outcome
Incidence of oncogenic HPV genotypes, co-infection with different HPV genotypes
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Guillemot, Pr, MD study director
Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / Université Versailles Saint-Quentin-en-Yvelines / INSERM
Elisabeth Delarocque-Astagneau, MD study director
Unité Pharmacoépidémiologie et maladies infectieuses (PhEMI), Institut Pasteur / UVSQ / Inserm
Emmanuelle Mathiot-Vicaigne, MD principal investigator
Versailles Saint-Quentin-en-Yvelines University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Various biological sampling in people with Infection by Human Papilloma Virus, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HPV detection at inclusion (all HPV genotypes) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.