Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts (VAC-WARTS)
Primary Purpose
Palmar or Plantar Warts
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Vaccination
Sponsored by
About this trial
This is an interventional treatment trial for Palmar or Plantar Warts focused on measuring WARTS, Vaccine HPV
Eligibility Criteria
Inclusion Criteria:
- Patients of age ≥ 15 years and 3 months with palmar or plantar 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 least one months of application of topical salicylic acid
- At least two sprays of liquid nitrogen
- 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:
- Recent (under 72 hours) Positive Covid test (PCR)
- 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)
Sites / Locations
- Hospital CochinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gardasil 9®
Placebo
Arm Description
Nonavalent HPV vaccine
NaCl 0.9 % solution for injection
Outcomes
Primary Outcome Measures
Complete remission of cutaneous warts
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
Secondary Outcome Measures
Quality of Life evaluated
Quality of Life will be evaluated with QoL Questionnaire (DLQI)
Pain (VAS)
Pain will be assess using VAS
Functional discomfort for walking and functional disability in hands
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
Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
Full Information
NCT ID
NCT04814446
First Posted
March 22, 2021
Last Updated
September 6, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04814446
Brief Title
Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
Acronym
VAC-WARTS
Official Title
Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
June 29, 2025 (Anticipated)
Study Completion Date
June 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The qHPV and nHPV has been used as a therapeutic approached for the treatment of cutaneous warts in case reports and some case series. Very recently, the Journal of the American Academy of Dermatology (JAAD)-the journal with the highest impact factor in the dermatological field- has published a review of all the cases reported in the scientific literature. The authors were strongly in favor of the use of the vaccine in case of difficult-to-treat warts and have highlighted the need for clinical trials. In the literature, 80 patients have been described with cutaneous warts treated by qHPV or nHPV with more than 50% of efficacy.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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmar or Plantar Warts
Keywords
WARTS, Vaccine HPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter national clinical trial, phase III, two parallel group randomized (in a 1:1 ratio)
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gardasil 9®
Arm Type
Experimental
Arm Description
Nonavalent HPV vaccine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9 % solution for injection
Intervention Type
Biological
Intervention Name(s)
Vaccination
Intervention Description
Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6
Primary Outcome Measure Information:
Title
Complete remission of cutaneous warts
Description
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Quality of Life evaluated
Description
Quality of Life will be evaluated with QoL Questionnaire (DLQI)
Time Frame
Inclusion, 2 months, 6 months, 7 months
Title
Pain (VAS)
Description
Pain will be assess using VAS
Time Frame
Inclusion, 2 months, 6 months, 7 months
Title
Functional discomfort for walking and functional disability in hands
Description
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.
Time Frame
Inclusion, 2 months, 6 months, 7 months
Title
Partial remission of cutaneous warts
Description
Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of age ≥ 15 years and 3 months with palmar or plantar 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 least one months of application of topical salicylic acid
At least two sprays of liquid nitrogen
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:
Recent (under 72 hours) Positive Covid test (PCR)
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan CHANAL, Dr
Phone
+33 1 58 41 18 25
Email
johan.chanal@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier CHOSIDOW, Pr
Phone
+33 1 49 81 21 11
Email
olivier.chosidow@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan CHANAL, Dr
Organizational Affiliation
Hospital Cochin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier CHOSIDOW, Pr
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan CHANAL, Dr
Phone
+33 1 58 41 18 25
Email
johan.chanal@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
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