VAC-WARTS

Phase 1

Conditions: HPV vaccine
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: CTIS2024-513671-40-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 146

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:, Painful warts (VAS = 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI))., No 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, 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 (in accordance to the approval of the vaccine) or refusing the principle of postponing vaccination., Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days), 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to evaluate if the nonavalent HPV vaccine, as compared to placebo, conduct to complete remission of difficult-to-treat palmar or plantar warts (failure of two treatments before inclusion) one month after the third injection in immunocompetent patients.;Secondary Objective: To assess the improvement of quality-of-life, To assess the improvement of pain, To assess the improvement for walking and hand impairment, To evaluate if the nonavalent HPV vaccine conduct to partial remission of difficult-to-treat palmar or plantar warts one month after the third injection in immunocompetent patients., To assess the number of new warts;Primary end point(s): Complete remission of cutaneous warts 7 months after the first injection of the vaccine

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Quality of Life will be evaluated with QoL Questionnaire (DLQI) at M0, M2, M6, M7;Secondary end point(s):Pain will be assess using VAS at M0, M2, M6, M7;Secondary end point(s):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;Secondary end point(s):Partial remission of cutaneous warts 7 months after the first injection of the vaccine.;Secondary end point(s):Number of warts appeared at M2, M6, M7