Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
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 and adjuvanted by Aldara™, a cream containing 5% of imiquimod
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
Clearance of HPV 16 and HPV 18 infection at Month 12 using a type specific, sensitive and quantitative HPV PCR assay.
Time frame: month 12
Clearance of HPV 16 and HPV 18 infection.
Time frame: Month 6, 15, 18, 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 30 more locations