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

  • STATUS
    Recruiting
  • End date
    Jun 29, 2026
  • participants needed
    146
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 7 October 2022

Summary

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.

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.

Details
Condition Palmar or Plantar Warts
Treatment Vaccination
Clinical Study IdentifierNCT04814446
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients of age ≥ 15 years and 3 months with palmar or plantar 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 least one months of application of topical salicylic acid
At least two sprays of liquid nitrogen
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

Recent (under 72 hours) Positive Covid test (PCR)
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)
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