NCT01957878

Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

A Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate ProCervix Efficacy to Clear HPV 16 and HPV 18 Infection in Women With Normal Cytology or ASCUS/LSIL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Genticel · Industry
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Genital Infection Viral
• HUMAN PAPILLOMA VIRUS

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	Placebo	Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-10-08
• Last updated: 2016-12-02

Locations

40 sites across 7 countries: Belgium, Finland, France, Germany, Netherlands, Spain, United Kingdom