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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Patients will receive 3 vaccinations of 3 mg VB10.16 at the pre-specified time points. VB10.16 will be administered intramuscularly in the area over the lateral deltoid muscle.
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Lower Saxony, Germany
IZD Institut für Zytologie und Dysplasie
Hanover, Lower Saxony, Germany
Medical School Hanover
Hanover, Lower Saxony, Germany
Klinikum Wolfsburg
Wolfsburg, Lower Saxony, Germany
Safety/tolerability
\- The percentage of patients with adverse events (AEs), including any dose-limiting toxicities (DLT), laboratory assessments and physical findings.
Time frame: 6 months (extended follow up for additional 6 months)
Immunogenicity
* 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.
Time frame: 6 months
Preliminary assessment of efficacy
* The percentage of patients with HPV16+ clearance. * The percentage of patients with lesion regression
Time frame: 6 months (extended follow up for additional 6 months)
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