Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts (VAC-WARTS)

January 21, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The qHPV and nHPV has been used as a therapeutic approached for the treatment of cutaneous warts in case reports and some case series. Very recently, the Journal of the American Academy of Dermatology (JAAD)-the journal with the highest impact factor in the dermatological field- has published a review of all the cases reported in the scientific literature. The authors were strongly in favor of the use of the vaccine in case of difficult-to-treat warts and have highlighted the need for clinical trials. In the literature, 80 patients have been described with cutaneous warts treated by qHPV or nHPV with more than 50% of efficacy.Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Hospital Cochin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of age ≥ 15 years and 3 months with palmar or plantar warts (including periungueal and back of hands or feet warts) since more than one year with:
  • ≥ 5 warts (X palmar and X plantar) or
  • ≥ 4 cm2 of Total surface involved by the warts (Y cm x Z cm).
  • Patients should have received two lines of treatment during the past year before inclusion, the last treatment must be at 3 weeks maximum before inclusion:
  • At total one month of application of topical salicylic acid, with minimum 3 weeks continuous.
  • At least two sprays of liquid nitrogen (two applications at the same session, or at different sessions with a few intervals).
  • Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
  • No topical or systemic immunosuppresive/ immunomodulating drugs
  • Women of childbearing potential must have a negative pregnancy test and an effective contraception (V1) and up the end of the vaccination period of 6 months;
  • Individuals affiliated to a social security regimen;
  • Individuals able to participate and to follow up during the study period.

Exclusion Criteria:

  • Suspicion of COVID, with confirmation by autotest.
  • Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
  • Women or men who received HPV Vaccine previously of the study;
  • Any serious chronic or progressive disease according to the judgement of the investigator;
  • Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
  • Individuals who have any malignancy or lymphoproliferative disorder;
  • Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;
  • Patient with anticoagulant therapy
  • Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;
  • Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, during the first 6 months ½ of the study;
  • Individuals under a measure of legal protection or unable to consent;
  • Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of the study.
  • Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
  • Patient on AME (state medical aid) (unless exemption from affiliation).
  • Patient wishing to be vaccinated with Gardasil 9® within 6 months or refusing the principle of postponing vaccination.
  • Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gardasil 9®
Nonavalent HPV vaccine
Biological: Vaccination
Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6
Placebo Comparator: Placebo
NaCl 0.9 % solution for injection
Biological: Vaccination
Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete remission of cutaneous warts
Time Frame: 7 months
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life evaluated
Time Frame: Inclusion, 2 months, 6 months, 7 months
Quality of Life will be evaluated with QoL Questionnaire (DLQI)
Inclusion, 2 months, 6 months, 7 months
Pain (VAS)
Time Frame: Inclusion, 2 months, 6 months, 7 months
Pain will be assess using VAS
Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands
Time Frame: Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands will be evaluated using the Revised Foot Function index or Cochin hand function scale respectively at M0, M2, M6, M7.
Inclusion, 2 months, 6 months, 7 months
Partial remission of cutaneous warts
Time Frame: 7 months
Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
7 months
Number of warts appeared
Time Frame: Inclusion, 2 months, 6 months, 7 months
Number of warts appeared at M2, M6, M7
Inclusion, 2 months, 6 months, 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johan CHANAL, Dr, Hospital Cochin
  • Study Director: Olivier CHOSIDOW, Pr, Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP200046
  • 2024-513671-40-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings