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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

11 Jan 2018 → 4 Nov 2025

Decision date (initial)

2024-12-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French Ministry of Health (PHRC-N 2015)

External identifiers

EU CT number

2024-516098-62-00

EudraCT number

2016-002455-20

ClinicalTrials.gov

NCT03296397

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 1

1. To investigate the clinical tolerance to three doses of HPV vaccine

Conditions and MedDRA coding

External Genital Warts (EGW)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients aged 18 years and older
2. 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
3. Patients with a confirmed clinical diagnosis for previous external anogenital warts
4. 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
5. 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
6. 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
7. Patients affiliated to a social security regimen
8. Patients able to participate during the 12 months of the study

Exclusion criteria 13

1. Patient with diagnosis of internal anogenital warts (intra rectal , intra vaginal, intra urethral) at the selection visit
2. Patients with positive HIV, HCV or HBV (Ag HBS) tests
3. Patients whose regular partner(s) have an active uncontrolled clinical EGW disease
4. Patients who received the HPV Vaccine at any time before enrolment to the study
5. Patients with any serious chronic or progressive disease according to the judgment of the investigator
6. 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
7. Patients with history of known allergies/hypersensitivity to any component of study vaccine
8. Patients who have any malignancy or lymphoproliferative disorder
9. Patients with thrombocytopenia or coagulation disorder contre- indicating intramusculary injections
10. 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
11. Male who do not use or do not plan to use condoms, during the first 6 months of the study
12. Patients under a measure of legal protection or unable to consent
13. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relapse-free “survival”. Relapse will have to be clinically confirmed.

Secondary endpoints 1

1. Percentage of patients with local and/or systemic reactions during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Sebastien Fouere

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Sebastien Fouere

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications