Patients whose EGW have just disappeared after initial success of classic treatment MedDRA version: 19.0 Level: PT Classification code 10059313 Term: Anogenital warts System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gardasil
Product Name: Gardasil
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Gardasil
Other descriptive name: Gardasil
Concentration unit: ml millilitre(s)
Concentrat
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 years and older ; - Patients who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements ; - Patients with a confirmed clinical diagnosis for previous external anogenital warts ; - Patient completely cured (no clinically visible lesions) for over two weeks and less than a month prior to inclusion visit (V1, M0) after initial success of classic treatment; - Women of childbearing potential must have a negative pregnancy test and an effective contraception from selection visit (V0) and up to the end of the vaccination period of 6 months; - Males must have an effective protection with condoms in order to limit the risk of recontamination from selection visit (V0) and up to the end of the vaccination period of 6 months ; - Patients affiliated to a social security regimen; - Patients able to participate during the 12 months of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Patient with diagnosis of internal anogenital warts (intra rectal , intra vaginal, intra urethral) at the selection visit - Patients with positive HIV, HCV or HBV (Ag HBS) tests; - Patients whose regular partner(s) have an active uncontrolled clinical EGW disease; - Patients who received the HPV Vaccine at any time before enrolment to the study; - Patients with any serious chronic or progressive disease according to the judgment of the investigator; - Patients with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days) (i.e. prednisone, or equivalent >=10 mg/day) within : o the 28 days preceding the first vaccination at the inclusion visit V1 in case of corticosteroids administration o the 3 months preceding the first vaccination at the inclusion visit V1 in case of administration of cyclophosphamide, anti-TNF-alpha, intravenous immunoglobulins, abatacep, corticosteroids as a bolus injection o the 6 months preceding the first vaccination at the inclusion visit V1 in case of anti CD 20 administration or in chemotherapy treatment within the past 180 days (6 months).Topical or inhaled uses of steroid including intranasal are allowed; - Patients with history of known allergies/hypersensitivity to any component of study vaccine ; - Patients who have any malignancy or lymphoproliferative disorder ; - Patients with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections ; - Women who are pregnant or are breast-feeding, or are of childbearing age and do not use or do not plan to use acceptable birth control measures, during the first 6 months of the study ; - Male who do not use or do not plan to use condoms, during the first 6 months of the study ; - Patients under a measure of legal protection or unable to consent ; - Patients participating in any clinical trial with another investigational product 28 days prior to first study visit or intent on participating in another clinical study at any time during the conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate if the HPV vaccine, as compared to placebo, reduces the relapse rate of external genital warts over a 12 month-period after their first injection.;Secondary Objective: - To assess the improvement of the quality of life of the patients - To investigate the clinical tolerance to three doses of HPV vaccine. ;Primary end point(s): The primary endpoint is the Relapse-free "survival". Relapse will have to be clinically confirmed.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Disease relief score as evaluated by patients on CECA and DLQI self-administered questionnaires over the treatment and follow-up periods 2. The clinical tolerance to HPV vaccine will be evaluated by assessment of the percentage of patients with local and/or systemic reactions during the study ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed