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 Information
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
Administrative Informations
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