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

NCT04814446 | Recruiting Phase 3

• 2 other identifiers: APHP2000462024-513671-40-00
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palmar or Plantar Warts

Keywords

WARTS; Vaccine HPV

Outcome Measures

Primary Outcomes (1)

• Complete remission of cutaneous warts

  Complete remission of cutaneous warts 7 months after the first injection of the vaccine

  7 months

Secondary Outcomes (5)

• Quality of Life evaluated

  Inclusion, 2 months, 6 months, 7 months

• Pain (VAS)

  Inclusion, 2 months, 6 months, 7 months

• Functional discomfort for walking and functional disability in hands

  Inclusion, 2 months, 6 months, 7 months

• Partial remission of cutaneous warts

  7 months

• Number of warts appeared

  Inclusion, 2 months, 6 months, 7 months

Study Arms (2)

Gardasil 9®

EXPERIMENTAL

Nonavalent HPV vaccine

Biological: Vaccination

Placebo

PLACEBO COMPARATOR

NaCl 0.9 % solution for injection

Biological: Vaccination

Interventions

Vaccination BIOLOGICAL

Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6

Gardasil 9®; Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Warts

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Johan CHANAL, Dr

  Hospital Cochin

  PRINCIPAL INVESTIGATOR

• Olivier CHOSIDOW, Pr

  Henri Mondor University Hospital

  STUDY DIRECTOR

Central Study Contacts

Johan CHANAL, Dr

CONTACT

+33 1 58 41 18 25; johan.chanal@aphp.fr

Olivier CHOSIDOW, Pr

CONTACT

+33 1 49 81 21 11; olivier.chosidow@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind clinical trial.The identity of Gardasil 9® vaccine and placebo cannot be concealed as presentation. They will be packed in boxes of identical appearance to achieve double blindness. During the study designated unblinded trained and qualified site staff will be responsible for preparing the Gardasil 9® vaccine or placebo out of view of patients and an unblinded nurse(s) or physician(s) will be responsible for administering the study products to the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter national clinical trial, phase III, two parallel group randomized (in a 1:1 ratio)

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: June 29, 2022
• Primary Completion: June 29, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: January 23, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)