Clinical trial NCT02946346: Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women
Official title: KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HPV Genital Infection (Primary Condition Studied)
Bacterial Vaginosis
Chlamydiae Infection
Keywords: Human papillomaviruses
Clearance
Kinetics
Ecology
Bacterial vaginosis
Immune response
Microbiota
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2016-10-27
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Times series of HPV virus load in cervical smears measured by qPCR
timeFrame: from detection to clearance or persistence (i.e. 3 to 24 months)
Secondary outcomes:
measure: Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance)
timeFrame: from detection to clearance or persistence (i.e. 3 to 24 months)
measure: Times series of vaginal cytokine densities measured using MesoScale Discovery technique
timeFrame: from detection to clearance or persistence (i.e. 3 to 24 months)
measure: Times series of anti-HPV circulating antibody titers
timeFrame: from detection to clearance or persistence (i.e. 3 to 24 months)
measure: Times series of the vaginal microbiota determined using 16S RNA and shotgun sequencing
timeFrame: from detection to clearance or persistence (i.e. 3 to 24 months)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pr Reynes
Study officials:
References:
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.
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.