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VAC-WARTS
EU CTIS ID: 2024-513671-40-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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).
- 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;
You likely can't join if
- 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).
See the full eligibility 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
- 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.