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

Primary Purpose

HPV Genital Infection (Primary Condition Studied), Bacterial Vaginosis, Chlamydiae Infection

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vaginal sampling
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HPV Genital Infection (Primary Condition Studied) focused on measuring Human papillomaviruses, Clearance, Kinetics, Ecology, Bacterial vaginosis, Immune response, Microbiota

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pr Reynes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaginal and blood sampling

Arm Description

Outcomes

Primary Outcome Measures

Times series of HPV virus load in cervical smears measured by qPCR
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

Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance)
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.
Times series of vaginal cytokine densities measured using MesoScale Discovery technique
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.
Times series of anti-HPV circulating antibody titers
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.
Times series of the vaginal microbiota determined using 16S RNA and shotgun sequencing
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.

Full Information

First Posted
August 22, 2016
Last Updated
October 13, 2020
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02946346
Brief Title
Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women
Acronym
PAPCLEAR
Official Title
KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty to continue follow-up during the coronavirus epidemic
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Genital Infection (Primary Condition Studied), Bacterial Vaginosis, Chlamydiae Infection
Keywords
Human papillomaviruses, Clearance, Kinetics, Ecology, Bacterial vaginosis, Immune response, Microbiota

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal and blood sampling
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
vaginal sampling
Primary Outcome Measure Information:
Title
Times series of HPV virus load in cervical smears measured by qPCR
Description
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.
Time Frame
from detection to clearance or persistence (i.e. 3 to 24 months)
Secondary Outcome Measure Information:
Title
Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance)
Description
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.
Time Frame
from detection to clearance or persistence (i.e. 3 to 24 months)
Title
Times series of vaginal cytokine densities measured using MesoScale Discovery technique
Description
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.
Time Frame
from detection to clearance or persistence (i.e. 3 to 24 months)
Title
Times series of anti-HPV circulating antibody titers
Description
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.
Time Frame
from detection to clearance or persistence (i.e. 3 to 24 months)
Title
Times series of the vaginal microbiota determined using 16S RNA and shotgun sequencing
Description
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.
Time Frame
from detection to clearance or persistence (i.e. 3 to 24 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Pr Reynes
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33939124
Citation
Selinger C, Rahmoun M, Murall CL, Bernat C, Boue V, Bonneau M, Graf C, Grasset S, Groc S, Reynes J, Hirtz C, Jacobs N, Alizon S. Cytokine response following perturbation of the cervicovaginal milieu during HPV genital infection. Immunol Res. 2021 Jun;69(3):255-263. doi: 10.1007/s12026-021-09196-2. Epub 2021 Apr 30.
Results Reference
derived
PubMed Identifier
31189673
Citation
Murall CL, Rahmoun M, Selinger C, Baldellou M, Bernat C, Bonneau M, Boue V, Buisson M, Christophe G, D'Auria G, Taroni F, Foulongne V, Froissart R, Graf C, Grasset S, Groc S, Hirtz C, Jaussent A, Lajoie J, Lorcy F, Picot E, Picot MC, Ravel J, Reynes J, Rousset T, Seddiki A, Teirlinck M, Tribout V, Tuaillon E, Waterboer T, Jacobs N, Bravo IG, Segondy M, Boulle N, Alizon S. Natural history, dynamics, and ecology of human papillomaviruses in genital infections of young women: protocol of the PAPCLEAR cohort study. BMJ Open. 2019 Jun 11;9(6):e025129. doi: 10.1136/bmjopen-2018-025129.
Results Reference
derived

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Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

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