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

Inclusion Criteria:

• Patients of age ≥ 15 years and 3 months with palmar or plantar warts (includingperiungueal 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 beforeinclusion, the last treatment must be at 3 weeks maximum before inclusion:

• At total one month of application of topical salicylic acid, with minimum 3 weekscontinuous.

• At least two sprays of liquid nitrogen (two applications at the same session, or atdifferent 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 effectivecontraception (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-marrowtransplantation, 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 theinvestigator;

• Individuals with history of known allergies/hypersensitivity to any component ofstudy vaccine;

• Individuals who have any malignancy or lymphoproliferative disorder;

• Individuals with thrombocytopenia or coagulation disorder contre-indicatingintramusculary 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 havenot used or do not plan to use acceptable birth control measures, during the first 6months 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 clinicalstudy at any time during the conduct of the study.

• Participation in another interventional study involving human participants or beingin 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 theprinciple of postponing vaccination.

• Immunosuppressive therapy including use of systemic corticosteroids or chronicimmunosuppressant medication (more than 14 days)