Vac-Warts

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

29 Jun 2022 → ongoing

Decision date (initial)

2024-07-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513671-40-00

EudraCT number

2021-000333-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 5

1. To assess the improvement of quality-of-life
2. To assess the improvement of pain
3. To assess the improvement for walking and hand impairment
4. To evaluate if the nonavalent HPV vaccine conduct to partial remission of difficult-to-treat palmar or plantar warts one month after the third injection in immunocompetent patients.
5. To assess the number of new warts

Conditions and MedDRA coding

HPV vaccine

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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).
2. 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:
3. Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
4. No systemic immunosuppresive/ immunomodulating drugs
5. 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;
6. Individuals affiliated to a social security regimen;
7. Individuals able to participate and to follow up during the study period

Exclusion criteria 16

1. Suspicion of COVID, with confirmation by autotest
2. Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
3. Women or men who received HPV Vaccine previously of the study;
4. Any serious chronic or progressive disease according to the judgement of the investigator;
5. Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
6. Individuals who have any malignancy or lymphoproliferative disorder;
7. Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;
8. Patient with anticoagulant therapy
9. Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;
10. 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
11. Individuals under a measure of legal protection or unable to consent;
12. 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
13. 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
14. Patient on AME (state medical aid) (unless exemption from affiliation).
15. 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.
16. Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

1. Quality of Life will be evaluated with QoL Questionnaire (DLQI) at M0, M2, M6, M7
2. Pain will be assess using VAS at M0, M2, M6, M7
3. 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
4. Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
5. Number of warts appeared at M2, M6, M7

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating Investigator

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Coordinating Investigator

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications