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

NCT ID: NCT02529930

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-01-31

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.

Conditions

High Grade Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

VB10.16 Immunotherapy (DNA vaccine)

Intervention Type: BIOLOGICAL

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.

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

Group Type: EXPERIMENTAL

VB10.16 Immunotherapy (DNA vaccine)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Biological/Vaccine

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theradex

INDUSTRY

Sponsor Role: collaborator

Vaccibody AS

INDUSTRY

Sponsor Role: collaborator

Nykode Therapeutics ASA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene Skjørestad, MSc

Role: STUDY_DIRECTOR

Vaccibody AS

Locations

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

Countries

Germany

References

Hillemanns P, Denecke A, Woelber L, Bohmer G, Jentschke M, Schjetne KW, Bruins Slot KMH, Fredriksen AB. A Therapeutic Antigen-Presenting Cell-Targeting DNA Vaccine VB10.16 in HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia: Results from a Phase I/IIa Trial. Clin Cancer Res. 2022 Nov 14;28(22):4885-4892. doi: 10.1158/1078-0432.CCR-22-1927.

Reference Type: DERIVED

PMID: 36129459 (View on PubMed)

Other Identifiers

VB C-01

Identifier Type: -

Identifier Source: org_study_id