Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

Bacterial Vaginosis Clinical Trial

— PAPCLEAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02946346
• Other study ID #: UF 9554
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Chlamydia Infections
• Chlamydiae Infection
• Communicable Diseases
• HPV Genital Infection (Primary Condition Studied)
• Infection
• Vaginal Diseases
• Vaginosis, Bacterial

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)