A Phase 3 interventional study of Vaccination with Gardasil and Injection of Normal Saline in Genital Warts, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Prevention
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
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) :
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
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's planned enrollment of 300 is above the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with history of an disorder or any other known or suspected impairment /alteration of the immune system, or under therapy including use of systemic or chronic immunosuppressant medication (more than 14 days) (i.e. prednisone, or equivalent ≥10 mg/day) within :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gardasil
Biological: Vaccination with Gardasil
Normal Saline
Biological: Injection of Normal Saline
Drug page: Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Vaccination with Gardasil in patients apparently cured of external genital warts
Injection of Normal Saline in patients apparently cured of external genital warts
Relapse free survival (days from first injection)
Time frame: up to 12 months
Improvement of quality of life by Dermatology Life Quality Index (DLQI) validated scale
Time frame: at each planned visit/phone contact (1, 2, 3, 6, 7, 9 months), at 12 months (upon end of study visit) or upon premature withdrawal visit
Improvement of quality of life by CECA validated scale
Time frame: at each planned visit/phone contact (1, 2, 3, 6, 7, 9 months), at 12 months (upon end of study visit) or upon premature withdrawal visit
Clinical tolerance of QHV (percentage of patients with AE)
Time frame: Day 0
Clinical tolerance of QHV
Time frame: Month 2 and Month 6
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
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