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

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: Recruiting
• Conditions: Palmar or Plantar Warts
• Intervention / Treatment: Biological: Vaccination

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: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Johan CHANAL, Dr; Phone Number: +33 1 58 41 18 25; Email: johan.chanal@aphp.fr
• Study Contact Backup: Name: Olivier CHOSIDOW, Pr; Phone Number: +33 1 49 81 21 11; Email: olivier.chosidow@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Hospital Cochin
    • Contact: Johan CHANAL, Dr; Phone Number: +33 1 58 41 18 25; Email: johan.chanal@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Complete remission of cutaneous warts	Complete remission of cutaneous warts 7 months after the first injection of the vaccine	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life evaluated	Quality of Life will be evaluated with QoL Questionnaire (DLQI)	Inclusion, 2 months, 6 months, 7 months
Pain (VAS)	Pain will be assess using VAS	Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands	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	Partial remission of cutaneous warts 7 months after the first injection of the vaccine.	7 months
Number of warts appeared	Number of warts appeared at M2, M6, M7	Inclusion, 2 months, 6 months, 7 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Johan CHANAL, Dr, Hospital Cochin; Study Director: Olivier CHOSIDOW, Pr, Henri Mondor University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Estimated): June 29, 2025
• Study Completion (Estimated): June 29, 2026

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: WARTS; Vaccine HPV
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Foot Diseases
• Other Study ID Numbers: EudraCT 2021-000333-13

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