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Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women (PAPCLEAR)

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ClinicalTrials.gov Identifier: NCT02946346
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Université Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear within a few months or years. There infections are much less studies than chronic infections, even though they represent the main reservoir for the virus. The goal of this project is to decipher the kinetics of the virus and of the host immune response in acute HPV genital infections in your women. This will be performed by following women longitudinally and regularly in order to measure variations in virus load, immune cell count, cytokine concentration and antibody titers. The investigators will also investigate the interaction between these kinetics and host genetics and host vaginal microbiota

Condition or disease Intervention/treatment Phase
HPV Genital Infection (Primary Condition Studied) Bacterial Vaginosis Chlamydiae Infection Other: vaginal sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
Actual Study Start Date : November 11, 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaginal and blood sampling Other: vaginal sampling



Primary Outcome Measures :
  1. Times series of HPV virus load in cervical smears measured by qPCR [ Time Frame: from detection to clearance or persistence (i.e. 3 to 24 months) ]
    This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.


Secondary Outcome Measures :
  1. Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance) [ Time Frame: from detection to clearance or persistence (i.e. 3 to 24 months) ]
    This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.

  2. Times series of vaginal cytokine densities measured using MesoScale Discovery technique [ Time Frame: from detection to clearance or persistence (i.e. 3 to 24 months) ]
    This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.

  3. Times series of anti-HPV circulating antibody titers [ Time Frame: from detection to clearance or persistence (i.e. 3 to 24 months) ]
    This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.

  4. Times series of the vaginal microbiota determined using 16S RNA and shotgun sequencing [ Time Frame: from detection to clearance or persistence (i.e. 3 to 24 months) ]
    This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexually active with at least one new partner over the last 12 months
  • Subjects must be able and willing to give written informed consent
  • Living in the 'agglomération de Montpellier'

Exclusion Criteria:

  • History of cervical pathology
  • Pregnant or intending to become pregnant soon (in the coming year)
  • Infected by HIV
  • Undergoing (or planning to undergo) heavy treatment (biotherapy, chemotherapy, immunosuppression)
  • Participation in a clinical trial involving administration of drugswithin the last 4 weeks before the screening date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946346


Contacts
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Contact: Samuel ALIZON samuel.alizon@cnrs.fr
Contact: Massilva Rahmoun massilva.rahmoun@ird.fr

Locations
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France
Pr Reynes Recruiting
Montpellier, France, 34295
Contact: Vincent Tribout         
Contact: Eric PICOT         
Sponsors and Collaborators
University Hospital, Montpellier
Université Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02946346     History of Changes
Other Study ID Numbers: UF 9554
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Human papillomaviruses
Clearance
Kinetics
Ecology
Bacterial vaginosis
Immune response
Microbiota

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Vaginal Diseases
Vaginosis, Bacterial
Chlamydia Infections
Genital Diseases, Female
Bacterial Infections
Vaginitis
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male