Status:
UNKNOWN
Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Genital Warts
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
External genital warts (EGW) are a frequent disease (typical yearly incidence of 100 to 200 new cases per 100.000 person-years, typical prevalence of 1 to 4% of the sexually active population), with a...
Eligibility Criteria
Inclusion
- 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 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. If the patient has an EGW relapse, they will not be randomized and will be considered as a screening failure. Screen-failed patients could perform another selection visit after being completely cured (no clinically visible lesions).
- 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 contraception with condoms 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.
Exclusion
- Patients with diagnosis of internal ano-genital warts (intra rectal, intra vaginal, intra urethral) at the selection visit
- Patients with positive HIV, Hepatitis C virus (HCV) or Hepatitis B virus (HBV) (Ag HBS) tests;
- Patients whose regular partner(s) have active uncontrolled clinical EGW;
- Patients who received the HPV Vaccine at any time before enrolment to the study;
- Any serious chronic or progressive disease according to the judgement 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 :
- the 28 days preceding the first vaccination at the inclusion visit V1 in case of corticosteroids administration
- the 3 months preceding the first vaccination at the inclusion visit V1 in case of administration of cyclophosphamide, anti-Tumor Necrosis Factor (TNF) alpha , intravenous immunoglobulins, abatacept, corticosteroids as a bolus injection
- the 6 months preceding the first vaccination at the inclusion visit V1 in case of Cluster of Differentiation antigen 20 (anti-CD20) administration. 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/treatment contra-indicating intramuscular injection;
- Women who are pregnant or are breast-feeding, or are of childbearing age who 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 to participate in another clinical study at any time during the conduct of this study.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03296397
Start Date
November 15 2017
End Date
April 1 2020
Last Update
February 27 2018
Active Locations (2)
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1
Hôpital St Louis
Paris, France, 75010
2
GH Cochin - Broca - Hôtel-Dieu,
Paris, France, 75679