Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

Not Applicable

Terminated

• Conditions: HPV Genital Infection (Primary Condition Studied); Bacterial Vaginosis; Chlamydiae Infection
• Interventions: Other: vaginal sampling

• Registration Number: NCT02946346
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-27
• Study Start: 2016-11-11
• Primary Completion: 2020-09-29
• Study Completion: 2020-09-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal and blood sampling	vaginal sampling	-

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Pr Reynes; 🇫🇷 Montpellier, France