An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)
- Conditions
- High Grade Cervical Intraepithelial Neoplasia
- Interventions
- Biological: VB10.16 Immunotherapy (DNA vaccine)
- Registration Number
- NCT02529930
- Lead Sponsor
- Nykode Therapeutics ASA
- Brief Summary
This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study will recruit approximately 27-40 female patients with high grade cervical intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.
- Detailed Description
The study will be divided into two phases, a dosing and expansion phase.
During the dosing phase the safety, tolerability and immunogenicity of 2 different vaccination schedules of 3 mg VB10.16 immunotherapy will be established in a minimum of 12 patients with histology confirmed CIN 2.
During the expansion phase the safety, tolerability and immunogenicity of the selected vaccination schedule will be evaluated in approximately 15 to 20 patients with histology confirmed HPV16+ CIN 2/3.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: 3mg VB10.16 Vaccine VB10.16 Immunotherapy (DNA vaccine) VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination Cohort 1: 3mg VB10.16 Vaccine VB10.16 Immunotherapy (DNA vaccine) VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination
- Primary Outcome Measures
Name Time Method Safety/tolerability 6 months (extended follow up for additional 6 months) - The percentage of patients with adverse events (AEs), including any dose-limiting toxicities (DLT), laboratory assessments and physical findings.
- Secondary Outcome Measures
Name Time Method Immunogenicity 6 months * The percentage of patients with E6/E7 specific cellular immune response in the blood.
* The percentage of patients with cellular immune response in the target lesions.
* The percentage of patients with humoral response against the E6/E7 viral antigen.Preliminary assessment of efficacy 6 months (extended follow up for additional 6 months) * The percentage of patients with HPV16+ clearance.
* The percentage of patients with lesion regression
Trial Locations
- Locations (4)
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Lower Saxony, Germany
Medical School Hanover
🇩🇪Hannover, Lower Saxony, Germany
IZD Institut für Zytologie und Dysplasie
🇩🇪Hannover, Niedersachsen, Germany
Klinikum Wolfsburg
🇩🇪Wolfsburg, Lower Saxony, Germany