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An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)

Primary Purpose

High Grade Cervical Intraepithelial Neoplasia

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

VB10.16 Immunotherapy (DNA vaccine)

About this trial

This is an interventional treatment trial for High Grade Cervical Intraepithelial Neoplasia focused on measuring HSIL, CIN 2/3, Therapeutic DNA vaccine, Human Papillomavirus, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria (abbreviated):

Women ≥18 years
Women with ectocervical HPV16+ associated High Grade Cervical Intraepithelial Neoplasia (HSIL) as verified by local pathology:
(Dosing Phase: Women with histologically confirmed HPV16+ associated CIN 2; Expansion Phase: Women with histologically confirmed HPV16+ associated CIN 2/3)
Satisfactory colposcopic examination.

Exclusion Criteria (abbreviated):

More than 2 cervical quadrants of CIN 3 as visualised by colposcopy.
Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease.
Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination.
Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
Administration of any blood product within 3 months of enrolment.
Concomitant or prior malignant disease.
Clinically significant autoimmune disease.
Known allergy to Kanamycin or other aminoglycosides
Known immunodeficiency and or immunosuppression.
History of toxic shock syndrome.
Evidence or history of clinically significant cardiac disease
Active infection requiring parenteral antibiotics.
Tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination or any implantable leads.
Immunosuppression
Major surgery within 3 months of trial entry.
Current or recent (within 30 days of first study treatment) participation in a clinical trial.
Previous vaccination (either therapeutic and/or prophylactic) against HPV.
Administration of any live vaccine within 90 days of trial entry.
Concomitant anticancer therapies.
Inadequate bone marrow function
Inadequate liver function
Clinical significant electrolyte abnormalities
Women of childbearing age not willing to use an effective form of contraception
Pregnancy or intention to become pregnant
Nursing women
Evidence of any other medical condition that may interfere with study participation, patient compliance or place the patient at high risk from treatment-related complications

Sites / Locations

Universitätsklinikum Hamburg-Eppendorf
Medical School Hanover
Klinikum Wolfsburg
IZD Institut für Zytologie und Dysplasie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1: 3mg VB10.16 Vaccine

Cohort 2: 3mg VB10.16 Vaccine

Arm Description

VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination

VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination

Outcomes

Primary Outcome Measures

Safety/tolerability

- The percentage of patients with adverse events (AEs), including any dose-limiting toxicities (DLT), laboratory assessments and physical findings.

Secondary Outcome Measures

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.

Preliminary assessment of efficacy

The percentage of patients with HPV16+ clearance. The percentage of patients with lesion regression

Full Information

NCT ID

NCT02529930

First Posted

August 19, 2015

Last Updated

July 11, 2022

Sponsor

Nykode Therapeutics ASA

Collaborators

Theradex, Vaccibody AS

1. Study Identification

Unique Protocol Identification Number

NCT02529930

Brief Title

An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)

Official Title

An Exploratory Safety and Immunogenicity Study of Human Papillomavirus (HPV16+) Immunotherapy VB10.16 in Women With High Grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2/3)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nykode Therapeutics ASA

Collaborators

Theradex, Vaccibody AS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Grade Cervical Intraepithelial Neoplasia

Keywords

HSIL, CIN 2/3, Therapeutic DNA vaccine, Human Papillomavirus, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: 3mg VB10.16 Vaccine

Arm Type

Experimental

Arm Description

VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination

Arm Title

Cohort 2: 3mg VB10.16 Vaccine

Arm Type

Experimental

Arm Description

VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination

Intervention Type

Biological

Intervention Name(s)

VB10.16 Immunotherapy (DNA vaccine)

Other Intervention Name(s)

Biological/Vaccine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety/tolerability

Description

- 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)

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

Time Frame

6 months

Title

Preliminary assessment of efficacy

Description

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (abbreviated): Women ≥18 years Women with ectocervical HPV16+ associated High Grade Cervical Intraepithelial Neoplasia (HSIL) as verified by local pathology: (Dosing Phase: Women with histologically confirmed HPV16+ associated CIN 2; Expansion Phase: Women with histologically confirmed HPV16+ associated CIN 2/3) Satisfactory colposcopic examination. Exclusion Criteria (abbreviated): More than 2 cervical quadrants of CIN 3 as visualised by colposcopy. Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). Administration of any blood product within 3 months of enrolment. Concomitant or prior malignant disease. Clinically significant autoimmune disease. Known allergy to Kanamycin or other aminoglycosides Known immunodeficiency and or immunosuppression. History of toxic shock syndrome. Evidence or history of clinically significant cardiac disease Active infection requiring parenteral antibiotics. Tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination or any implantable leads. Immunosuppression Major surgery within 3 months of trial entry. Current or recent (within 30 days of first study treatment) participation in a clinical trial. Previous vaccination (either therapeutic and/or prophylactic) against HPV. Administration of any live vaccine within 90 days of trial entry. Concomitant anticancer therapies. Inadequate bone marrow function Inadequate liver function Clinical significant electrolyte abnormalities Women of childbearing age not willing to use an effective form of contraception Pregnancy or intention to become pregnant Nursing women Evidence of any other medical condition that may interfere with study participation, patient compliance or place the patient at high risk from treatment-related complications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irene Skjørestad, MSc

Organizational Affiliation

Vaccibody AS

Official's Role

Study Director

Facility Information:

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

State/Province

Lower Saxony

ZIP/Postal Code

20246

Country

Germany

Facility Name

Medical School Hanover

City

Hannover

State/Province

Lower Saxony

ZIP/Postal Code

30625

Country

Germany

Facility Name

Klinikum Wolfsburg

City

Wolfsburg

State/Province

Lower Saxony

ZIP/Postal Code

38440

Country

Germany

Facility Name

IZD Institut für Zytologie und Dysplasie

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)

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