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

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)

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Safety/tolerability

Secondary Outcome

 Immunogenicity

Condition

High Grade Cervical Intraepithelial Neoplasia

Intervention

VB10.16 Immunotherapy (DNA vaccine)

Study Arms / Comparison Groups

 Cohort 1: 3mg VB10.16 Vaccine

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

34

Start Date

August 2015

Completion Date

January 31, 2019

Primary Completion Date

January 31, 2019

Eligibility 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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Irene Skjørestad, MSc, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT02529930

Organization ID

VB C-01

Responsible Party

Sponsor

Study Sponsor

Nykode Therapeutics ASA

Collaborators

 Theradex

Study Sponsor

Irene Skjørestad, MSc, Study Director, Vaccibody AS

Verification Date

July 2022