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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02946346
Other study ID # UF 9554
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 11, 2016
Est. completion date September 29, 2020

Study information

Verified date October 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 190
Est. completion date September 29, 2020
Est. primary completion date September 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
vaginal sampling


Locations

Country Name City State
France Pr Reynes Montpellier

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
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