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

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ClinicalTrials.gov Identifier: NCT02529930
Recruitment Status : Active, not recruiting
First Posted : August 20, 2015
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Theradex
Information provided by (Responsible Party):
Vaccibody AS

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.

Condition or disease Intervention/treatment Phase
High Grade Cervical Intraepithelial Neoplasia Biological: VB10.16 Immunotherapy (DNA vaccine) Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: 3mg VB10.16 Vaccine
VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination
Biological: VB10.16 Immunotherapy (DNA vaccine)
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.
Other Name: Biological/Vaccine

Experimental: Cohort 2: 3mg VB10.16 Vaccine
VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination
Biological: VB10.16 Immunotherapy (DNA vaccine)
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.
Other Name: Biological/Vaccine




Primary Outcome Measures :
  1. Safety/tolerability [ Time Frame: 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 :
  1. Immunogenicity [ Time Frame: 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.

  2. Preliminary assessment of efficacy [ Time Frame: 6 months (extended follow up for additional 6 months) ]
    • The percentage of patients with HPV16+ clearance.
    • The percentage of patients with lesion regression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (abbreviated):

  1. Women ≥18 years
  2. 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)

  3. Satisfactory colposcopic examination.

Exclusion Criteria (abbreviated):

  1. More than 2 cervical quadrants of CIN 3 as visualised by colposcopy.
  2. 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.
  3. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination.
  4. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
  5. Administration of any blood product within 3 months of enrolment.
  6. Concomitant or prior malignant disease.
  7. Clinically significant autoimmune disease.
  8. Known allergy to Kanamycin or other aminoglycosides
  9. Known immunodeficiency and or immunosuppression.
  10. History of toxic shock syndrome.
  11. Evidence or history of clinically significant cardiac disease
  12. Active infection requiring parenteral antibiotics.
  13. Tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination or any implantable leads.
  14. Immunosuppression
  15. Major surgery within 3 months of trial entry.
  16. Current or recent (within 30 days of first study treatment) participation in a clinical trial.
  17. Previous vaccination (either therapeutic and/or prophylactic) against HPV.
  18. Administration of any live vaccine within 90 days of trial entry.
  19. Concomitant anticancer therapies.
  20. Inadequate bone marrow function
  21. Inadequate liver function
  22. Clinical significant electrolyte abnormalities
  23. Women of childbearing age not willing to use an effective form of contraception
  24. Pregnancy or intention to become pregnant
  25. Nursing women
  26. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529930


Locations
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Lower Saxony, Germany, 20246
Medical School Hanover
Hannover, Lower Saxony, Germany, 30625
Klinikum Wolfsburg
Wolfsburg, Lower Saxony, Germany, 38440
IZD Institut für Zytologie und Dysplasie
Hannover, Niedersachsen, Germany, 30159
Sponsors and Collaborators
Vaccibody AS
Theradex
Investigators
Study Director: Irene Skjørestad, MSc Vaccibody AS

Responsible Party: Vaccibody AS
ClinicalTrials.gov Identifier: NCT02529930     History of Changes
Other Study ID Numbers: VB C-01
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vaccibody AS:
HSIL
CIN 2/3
Therapeutic DNA vaccine
Human Papillomavirus
Immunotherapy

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs