Genital Warts Clinical Trial
Official title:
Efficacy Study of the Quadrivalent Human Papilloma Virus (HPV) Vaccine to Prevent Recurrence of External Genital Warts (EGW) in Patients Who Were Cured in the First Place
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 heavy toll on patients' quality of life: low self-esteem and severe
impairment of sexual well-being are common consequences. Treatments are painful and take time
to achieve cure because of low complete remission (20 to 60%) and high recurrence rates (10
to 40%, 30% on average). Finding new means to reduce these recurrence rates thus seems
justified. Infection with Human Papillomavirus (HPV) is responsible for EGW,other warts and
some epithelial cancers. Out of two currently available HPV vaccines (Cervarix and
Gardasil®), only Gardasil® is " quadrivalent " i.e. contains virus like particles imparting
protection versus 4 genotypes of HPV, 2 of them responsible of most cancers and pre cancers
of the cervix (HPV 16 and 18), and 2 for 90% of EGW (HPV 6 and 11). A close to 100 % efficacy
of the quadrivalent HPV vaccine (QHV) on prevention of EGW in naive patients has been shown,
leading to their near disappearance in the vaccinated population of countries with a good
vaccine coverage. Beside this preventive efficacy, literature data also show that HPV
vaccines have an up-to-100% protective effect versus recurrence of destroyed precancerous
lesions of the cervix in non-naive patients with an up-to-40 month's follow-up. Also, there
is anecdotal evidence that they could help treat severe wart conditions. QHV is also safe and
well tolerated when used in a preventive manner.
Investigator hypothesis is that QHV could have a protective effect on the recurrence of EGW
in patients who achieve complete remission.
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.
The primary endpoint is the Relapse-free "survival". Relapse will have to be clinically
confirmed.
The secondary objectives are : 1. To assess the improvement of the quality of life of the
patients 2. To investigate the clinical tolerance to three doses of HPV vaccine. The
secondary endpoints are
1. Disease relief score as evaluated by patients on a specific questionnaire for
Condylomata Acuminata (CECA) and Dermatology Life Quality Index (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
This is a National multicenter Phase III comparative, double blind randomized, two-parallel
groups clinical trial evaluating the efficacy of Gardasil vaccine versus placebo in EGW
population. Patients (300) recently cured of EGW will be enrolled over a 18 month-period and
will be randomized in a 1:1 ratio to receive three intra muscular (IM) vaccinations of either
Gardasil vaccine (150 subjects) or placebo (150 subjects) :
- Group 1: Gardasil (at M0) + Gardasil (at M2) + Gardasil (at M6)
- Group 2: Placebo (at M0) + Placebo (at M2) + Placebo (at M6) Subjects meeting all the
inclusion criteria and none of the exclusion criteria will be vaccinated by the
investigator or designee of the investigational center and will be examined by the
investigator or designee 30 minutes post immunization to assess for local and systemic
reactions.
All subjects will be followed by the investigators or designee during the study by phone
contacts and visits on site. Diary cards will be used after each vaccination to follow the
patients.
Number of visits /participant: 9 Schedule of visits : 1 selection visit (V0) , 3 vaccinations
scheduled on site at M0, M2 and M6, 3 phone contacts at M1, M3 and M7, 2 clinical follow up
visits on site at M9 and M12 + 1 unscheduled visit on site in case of EGW relapse during the
study
n/a
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