Using a nonavalent HPV vaccine to treat difficult palmo-plantar warts

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

This study is testing if a new HPV vaccine can help people aged 15 and older get rid of stubborn warts on their hands and feet that haven't responded to other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT04814446 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of a nonavalent HPV vaccine in treating patients aged 15 years and older with difficult-to-treat palmo-plantar warts. Participants must have had these warts for over a year and have previously undergone at least two lines of treatment without success. The study aims to determine if vaccination can lead to complete resolution of these warts. The approach is based on previous case reports and literature suggesting the potential effectiveness of HPV vaccination in wart treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 years and 3 months or older with persistent palmo-plantar warts that have not responded to prior treatments.

Not a fit: Patients who have not had prior treatments for their warts or those with immunosuppressive conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from persistent palmo-plantar warts.

How similar studies have performed: Previous case reports have shown over 50% efficacy in treating cutaneous warts with HPV vaccines, indicating potential success for this approach.

Eligibility criteria

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:
* 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.

Exclusion Criteria:

* 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.
* 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)

Where this trial is running

Paris

• Hospital Cochin — Paris, France (Recruiting)

Study contacts

• Principal investigator: Johan CHANAL, Dr — Hospital Cochin
• Study coordinator: Johan CHANAL, Dr

Conditions Palmar or Plantar Warts; WARTS; Vaccine HPV