VAC-WARTS

Phase 3

Recruiting

• Conditions: HPV vaccine

• Registration Number: 2024-513671-40-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-24
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• 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
Complete remission of cutaneous warts 7 months after the first injection of the vaccine		Complete remission of cutaneous warts 7 months after the first injection of the vaccine

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

Centre Hospitalier Universitaire Reims; 🇫🇷 Reims, France

Hospital Edouard Herriot; 🇫🇷 Lyon, France

CHU De Bordeaux; 🇫🇷 Bordeaux Cedex, France

Centre Hospitalier Intercommunal De Frejus-Saint-Raphaeel; 🇫🇷 Frejus, France

Centre Hospitalier Intercommunal Creteil; 🇫🇷 Creteil, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Chambray Les Tours, France

Centre Hospitalier William Morey; 🇫🇷 Chalon Sur Saone Cedex, France

HIA Sainte Anne; 🇫🇷 Toulon Cedex 9, France

CHU Besancon; 🇫🇷 Besancon Cedex, France

Assistance Publique Hopitaux De Paris

🇫🇷Paris, France

Tu-Anh Duong-Eclancher

Site contact

+3349094429

tu-anh.duong@aphp.fr

Vincent Descamps

Site contact

+33140258240

vincent.descamps@aphp.fr

Gérome Bohelay

Site contact

+33148955585

gerome.bohelay@aphp.fr

sebastien Fouere

Site contact

+33142499961

sebastien.fouere@aphp.fr

Johan Chanal

Site contact

+33158411825

johan.chanal@aphp.fr