HPV Genital Infection (Primary Condition Studied)PAPCLEARNCT02946346
Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women
A study testing vaginal sampling in people with HPV Genital Infection (Primary Condition Studied) and Bacterial Vaginosis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Genital Infection (Primary Condition Studied), Bacterial Vaginosis, Chlamydiae Infection
- What is being tested?
- vaginal sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2016to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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'
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
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
- Being tested
- vaginal sampling
- Keywords
- Human papillomaviruses, Clearance, Kinetics, Ecology, Bacterial vaginosis, Immune response, Microbiota
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal samplingOther
| Study group | Role | What they receive |
|---|---|---|
| Vaginal and blood sampling | Experimental | Not described Receives: Other: vaginal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: from detection to clearance or persistence (i.e. 3 to 24 months)
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.
Measured: from detection to clearance or persistence (i.e. 3 to 24 months)
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.
Measured: 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
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.
Measured: from detection to clearance or persistence (i.e. 3 to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start11 Nov 2016
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Why it stopped: Difficulty to continue follow-up during the coronavirus epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV Genital Infection (Primary Condition Studied)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946346
- Sponsor's protocol ID
- RECHMPL16_0149
- Other IDs
- 2016-A00712-49
- Acronym
- PAPCLEAR
- Status last verified
- Oct 2020
- First submitted
- 22 Aug 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39836629Selinger 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.
PubMed 33939124Murall 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.
PubMed 31189673
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
- ClinicalTrials.gov ID
- NCT02946346
- Acronym / sponsor ID
- PAPCLEAR / RECHMPL16_0149
- Conditions
- HPV Genital Infection (Primary Condition Studied), Bacterial Vaginosis, Chlamydiae Infection
- Keywords
- Human papillomaviruses, Clearance, Kinetics, Ecology, Bacterial vaginosis, Immune response, Microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to continue follow-up during the coronavirus epidemic
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal and blood sampling | Experimental | Other: vaginal sampling |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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'
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal sampling | Other | Vaginal and blood sampling |
Primary outcome
Times series of HPV virus load in cervical smears measured by qPCR
Time frame: 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.
4 secondary outcomes
Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance)
Time frame: from detection to clearance or persistence (i.e. 3 to 24 months)
Times series of vaginal cytokine densities measured using MesoScale Discovery technique
Time frame: from detection to clearance or persistence (i.e. 3 to 24 months)
Times series of anti-HPV circulating antibody titers
Time frame: 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
Time frame: from detection to clearance or persistence (i.e. 3 to 24 months)
Results and safety
The study was stopped early (reason given: Difficulty to continue follow-up during the coronavirus epidemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 39836629Tessandier 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.
- Derived from this study: PubMed 33939124Selinger 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.
- Derived from this study: PubMed 31189673Murall 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal sampling in people with HPV Genital Infection (Primary Condition Studied) and Bacterial Vaginosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty to continue follow-up during the coronavirus epidemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Times series of HPV virus load in cervical smears measured by qPCR (time frame: from detection to clearance or persistence (i.e. 3 to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946346, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.