Genital WartsPhase 3CONDYVACNCT03296397
Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response
A Phase 3 study testing Vaccination with Gardasil and Injection of Normal Saline in people with Genital Warts, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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 heavy toll on patients' quality of life: low self-esteem and severe impairment of sexual well-being are common… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genital Warts
- What is being tested?
- Vaccination with Gardasil and Injection of Normal Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Nov 2017to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 :
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital St Louis
Paris, 75010
Sebastien FOUERE, MD, MSc, (0)1 42 49 99 24, sebastien.fouere@aphp.fr
- Not yet recruiting
GH Cochin - Broca - Hôtel-Dieu,
Paris, 75679
Odile LAUNAY, PH, (0)1 58 41 28 58 ext. +33, odile.launay@aphp.fr
Laurence MOULAY, (0)1 58 41 24 51 ext. +33, laurence.moulay@aphp.fr
About this study
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.
Read more
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
- 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
- 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
- Conditions
- Genital Warts
- Being tested
- Vaccination with Gardasil, Injection of Normal Saline
- Keywords
- Genital warts, HPV vaccine, Relapse
- Medical subject headings
- Condylomata Acuminata, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with GardasilBiological
Vaccination with Gardasil in patients apparently cured of external genital warts
Injection of Normal SalineBiological
Injection of Normal Saline in patients apparently cured of external genital warts
| Study group | Role | What they receive |
|---|---|---|
| HPV Quadrivalent vaccine (QHV) | Active comparator | Gardasil Receives: Biological: Vaccination with Gardasil |
| Placebo | Placebo comparator | Normal Saline Receives: Biological: Injection of Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival (days from first injection)
Measured: up to 12 months
Secondary outcomes (4)
Improvement of quality of life by Dermatology Life Quality Index (DLQI) validated scale
Measured: 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
Measured: 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)
Measured: Day 0
Clinical tolerance of QHV
Measured: Month 2 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start15 Nov 2017
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital WartsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien FOUERE, MD, MSc, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296397
- Sponsor's protocol ID
- P150957
- Acronym
- CONDYVAC
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03296397
- Acronym / sponsor ID
- CONDYVAC / P150957
- Conditions
- Genital Warts
- Keywords
- Genital warts, HPV vaccine, Relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Quadrivalent vaccine (QHV) | Active comparator | Biological: Vaccination with GardasilGardasil |
| Placebo | Placebo comparator | Biological: Injection of Normal SalineNormal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination with GardasilVaccination with Gardasil in patients apparently cured of external genital warts | Biological | HPV Quadrivalent vaccine (QHV) |
| Injection of Normal SalineInjection of Normal Saline in patients apparently cured of external genital warts | Biological | Placebo |
Primary outcome
Relapse free survival (days from first injection)
Time frame: up to 12 months
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien FOUERE, MD, MSc principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccination with Gardasil and Injection of Normal Saline in people with Genital Warts, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastien FOUERE, MD, MSc ((0)1 42 49 99 24 ext. +33, sebastien.fouere@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (days from first injection) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.