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

PHASE2CompletedINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Genital Infection ViralHUMAN PAPILLOMA VIRUS
Interventions
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

Trial Locations (40)

Unknown

Regionaal Ziekenhuis Heilig Hart Tienen Hospital, Tienen

Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute (VAXINFECTIO) Faculty of Medicine University of Antwerp Belgium, Antwerp

Grand Hôpital de Charleroi Site Notre-Dame, Charleroi

University Hospitals Leuven, Leuven

Helsinki University Central Hospital, Helsinki

Kuopio University Hospital, Kuopio

Tampereen yliopistollinen sairaala Hospital, Tampere

CHU Amiens Hopital Sud, Amiens

Hôpital Saint Jacques, Besançon

GORH, CHU Estaing, Clermont-Ferrand

CHU Dijon, Dijon

Hôpital Jeanne de Flandre CHU de Lille, Lille

CHU de Nîmes - Hopital Universitaire Caremeau, Nîmes

Centre d'Investigation Clinique de Vaccinologie Cochin Pasteur (CIC BT505), Paris

Centre Hospitalier Lyon Sud, Pierre-Bénite

CHU de Reims Institut Alix de Champagne, Reims

Hôpital de Hautepierre, Strasbourg

Charité - Universitätsmedizin Berlin Hospital, Berlin

Universitätsklinikum Erlangen Hospital, Erlangen

Elisabeth Krankenhaus Essen GmbH - Clinic/Outpatient Facility, Essen

Klinikum der Friedrich Schiller Universität Jena Hospital, Jena

LMU Klinikum der Universität- Hospital, München

Klinikum Wolfsburg Hospital, Wolfsburg

Center Gynaecological Oncology Amsterdam AMC, NKI-AVL, VUmc, Amsterdam

St. Antonius Ziekenhuis Hospital, Nieuwegein

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

Hospital del Mar, Barcelona

Hospital Universitari Vall D Hebron, Barcelona

Institut Catala d'Oncologia L'Hopitalet de Llobregat, Barcelona

Clinica Ginecologica Ceoga, Clinic/Outpatient Facility, Lugo

Hospital Clínico San Carlos, Madrid

Hospital La Paz de Madrid, Madrid

"Hospital Universitario 12 de Octubre", Madrid

Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil, Málaga

Hospital Sagrado Corazón de Sevilla, Seville

Dumfries and Galloway Royal Infirmary Hospital, Dumfries

Liverpool - GUM - Liverpool Centre for Sexual Health, Liverpool

St Mary's Hospital, London

Academic O&G University of Manchester Research - St Mary's Hospital, Manchester

The Centre for Immunology and Infection Hull York Medical School University of York, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genticel

INDUSTRY

NCT01957878 - Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL | Biotech Hunter | Biotech Hunter