Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

NCT02946346 | Terminated

• 2 other identifiers: RECHMPL16_01492016-A00712-49
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

HPV Genital Infection (Primary Condition Studied); Bacterial Vaginosis; Chlamydiae Infection

Keywords

Human papillomaviruses; Clearance; Kinetics; Ecology; Bacterial vaginosis; Immune response; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• Times series of vaginal cytokine densities measured using MesoScale Discovery technique

  from detection to clearance or persistence (i.e. 3 to 24 months)

• Times series of anti-HPV circulating antibody titers

  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

  from detection to clearance or persistence (i.e. 3 to 24 months)

Study Arms (1)

Vaginal and blood sampling

EXPERIMENTAL

Other: vaginal sampling

Interventions

vaginal sampling OTHER

Vaginal and blood sampling

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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'

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

Pr Reynes

Montpellier, Montpellier, 34295, France

Location

Related Publications (3)

• Tessandier N, Elie B, Boue V, Selinger C, Rahmoun M, Bernat C, Grasset S, Groc S, Bedin AS, Beneteau T, Bonneau M, Graf C, Jacobs N, Kamiya T, Kerioui M, Lajoie J, Melki I, Pretet JL, Reyne B, Schlecht-Louf G, Sofonea MT, Supplisson O, Wymant C, Foulongne V, Guedj J, Hirtz C, Picot MC, Reynes J, Tribout V, Tuaillon E, Waterboer T, Segondy M, Bravo IG, Boulle N, Murall CL, Alizon S. Viral and immune dynamics of genital human papillomavirus infections in young women with high temporal resolution. PLoS Biol. 2025 Jan 21;23(1):e3002949. doi: 10.1371/journal.pbio.3002949. eCollection 2025 Jan.

  PMID: 39836629 DERIVED

• 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.

  PMID: 33939124 DERIVED

• 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.

  PMID: 31189673 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: October 27, 2016
• Study Start: November 11, 2016
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: September 30, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)