Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

Study Overview
=================
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

Official Title
-----------------
KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN

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

Intervention / Treatment
-----------------
* Other: vaginal sampling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal and blood sampling<br> | Other: vaginal sampling<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from detection to clearance or persistence (i.e. 3 to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from detection to clearance or persistence (i.e. 3 to 24 months) | 
| 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. | from detection to clearance or persistence (i.e. 3 to 24 months) | 
| 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. | from detection to clearance or persistence (i.e. 3 to 24 months) | 
| 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. | from detection to clearance or persistence (i.e. 3 to 24 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human papillomaviruses, Clearance, Kinetics, Ecology, Bacterial vaginosis, Immune response, Microbiota