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CONDYVAC. 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
EU CTIS ID: 2024-516098-62-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patient with diagnosis of internal anogenital warts (intra rectal , intra vaginal, intra urethral) at the selection visit
- 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
- Patients with positive HIV, HCV or HBV (Ag HBS) tests
See the full eligibility criteria
Who can 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 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
What rules you out
- Patient with diagnosis of internal anogenital warts (intra rectal , intra vaginal, intra urethral) at the selection visit
- 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
- 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 : • 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-TNF- alpha, intravenous immunoglobulins, abatacep, corticosteroids as a bolus injection • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.