Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL
NCT ID: NCT01957878
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2013-12-31
2016-10-31
Brief Summary
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This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).
ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.
The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HPV therapeutic vaccine
ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
ProCervix
ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
Placebo matching ProCervix
Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
Placebo
Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
Interventions
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ProCervix
ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
Placebo
Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
Eligibility Criteria
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Inclusion Criteria
1. Subject is female between the ages of 25 and 50 years (inclusive).
2. Subject is pre-menopausal .
3. Subject must have cervical HPV 16 and/or 18 infection confirmed by RT-PCR
4. Subject has a cervical cytological evaluation with a normal, ASCUS or LSIL result at baseline.
5. Subject has employed highly effective contraception the month prior to the first vaccination and will agree to employ highly effective contraception for at least 12 months after the first vaccination. .
6. Subject is in general good health based on medical history and physical examination.
7. Subject is able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
8. Subject voluntarily gives written informed consent to participate in the study.
Exclusion Criteria
2. Subject has vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators (SERMs).
3. Subject has prior exposure to HPV prophylactic vaccine or subject has participated in the past in another vaccination clinical trial related to infection with HPV
4. Current high grade lesions or history of untreated high grade cervical lesion (either CIN2 or CIN3).
5. Subject has current or a history of cancer of the cervix.
6. Subject has clinically significant (CS) gynaecological abnormalities that could interfere with study evaluation, in the judgment of the Investigator (e.g. prolapse, myoma, fibroid, hysterectomy).
7. Subject has a laboratory abnormality Grade ≥ 2, as defined using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials,
8. Subject has received any live viral vaccine within 3 months or any other non live vaccine within 2 weeks of first study product administration.
9. Subject has primary or secondary systemic immunosuppression
10. Subject has a history of severe allergy (requiring hospital care) or history of severe asthma
11. Subject has a history of malignant cancer, except the following adequately treated cancers: basal cell carcinoma, or dermatological squamous cell carcinoma.
12. Subject was administered with another investigational drug or vaccine within 30 days prior to the screening visit or is participating in any other study.
13. Subject has a known hypersensitivity to imiquimod.
14. Subject has a history of severe reaction to any drug or vaccination.
15. Subject has a medical condition with clinical and/or biological consequences judged by the Investigator incompatible with vaccination(s).
16. Subject has positive results for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (HBsAg), or hepatitis C virus (HCV).
17. Subject has a symptomatic vaginal or genital infection
18. Subject has a history of or currently active genital herpes disease.
19. Subject is pregnant or is breastfeeding.
20. Subject has a positive serum human chorionic gonadotrophin (HCG) result at enrolment.
25 Years
50 Years
FEMALE
No
Sponsors
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Genticel
INDUSTRY
Responsible Party
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Locations
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Regionaal Ziekenhuis Heilig Hart Tienen Hospital
Tienen, Vlaams Brabant, Belgium
Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute (VAXINFECTIO) Faculty of Medicine University of Antwerp Belgium
Antwerp, , Belgium
Grand Hôpital de Charleroi Site Notre-Dame
Charleroi, , Belgium
University Hospitals Leuven
Leuven, , Belgium
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Tampereen yliopistollinen sairaala Hospital
Tampere, , Finland
CHU Amiens Hopital Sud
Amiens, , France
Hôpital Saint Jacques
Besançon, , France
GORH, CHU Estaing
Clermont-Ferrand, , France
CHU Dijon
Dijon, , France
Hôpital Jeanne de Flandre CHU de Lille
Lille, , France
CHU de Nîmes - Hopital Universitaire Caremeau
Nîmes, , France
Centre d'Investigation Clinique de Vaccinologie Cochin Pasteur (CIC BT505)
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Reims Institut Alix de Champagne
Reims, , France
Hôpital de Hautepierre
Strasbourg, , France
Charité - Universitätsmedizin Berlin Hospital
Berlin, , Germany
Universitätsklinikum Erlangen Hospital
Erlangen, , Germany
Elisabeth Krankenhaus Essen GmbH - Clinic/Outpatient Facility
Essen, , Germany
Klinikum der Friedrich Schiller Universität Jena Hospital
Jena, , Germany
LMU Klinikum der Universität- Hospital
München, , Germany
Klinikum Wolfsburg Hospital
Wolfsburg, , Germany
Center Gynaecological Oncology Amsterdam AMC, NKI-AVL, VUmc
Amsterdam, , Netherlands
St. Antonius Ziekenhuis Hospital
Nieuwegein, , Netherlands
Hospital Clinic Dept of Obstetrics and Gynecology C/ Villarroel Unidad de Ginecología Oncológica, Instituto Clínico de Ginecología y Obstetricia y Neonatología (ICGON), Hospital Clínic, Instituto de Investigaciones Biomédi
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Institut Catala d'Oncologia L'Hopitalet de Llobregat
Barcelona, , Spain
Clinica Ginecologica Ceoga, Clinic/Outpatient Facility
Lugo, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital La Paz de Madrid
Madrid, , Spain
Hospital Universitario "12 de Octubre"
Madrid, , Spain
Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil
Málaga, , Spain
Hospital Sagrado Corazón de Sevilla
Seville, , Spain
Dumfries and Galloway Royal Infirmary Hospital
Dumfries, , United Kingdom
Liverpool - GUM - Liverpool Centre for Sexual Health
Liverpool, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Academic O&G University of Manchester Research - St Mary's Hospital
Manchester, , United Kingdom
The Centre for Immunology and Infection Hull York Medical School University of York
York, , United Kingdom
Countries
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Other Identifiers
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PC10VAC02
Identifier Type: -
Identifier Source: org_study_id
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