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

NCT02529930 | Completed Phase 1 DMC

• 1 other identifier: VB C-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

High Grade Cervical Intraepithelial Neoplasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety/tolerability

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

  6 months (extended follow up for additional 6 months)

Secondary Outcomes (2)

• Immunogenicity

  6 months

• Preliminary assessment of efficacy

  6 months (extended follow up for additional 6 months)

Study Arms (2)

Cohort 1: 3mg VB10.16 Vaccine

EXPERIMENTAL

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)

Cohort 2: 3mg VB10.16 Vaccine

EXPERIMENTAL

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)

Interventions

VB10.16 Immunotherapy (DNA vaccine) 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.

Also known as: Biological/Vaccine

Cohort 1: 3mg VB10.16 Vaccine; Cohort 2: 3mg VB10.16 Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nykode Therapeutics ASA: lead
• Theradex: collaborator
• Vaccibody AS: collaborator

Study Sites (4)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Lower Saxony, 20246, Germany

Location

IZD Institut für Zytologie und Dysplasie

Hanover, Lower Saxony, 30159, Germany

Location

Medical School Hanover

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum Wolfsburg

Wolfsburg, Lower Saxony, 38440, Germany

Location

Related Publications (1)

• 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.

  PMID: 36129459 DERIVED

MeSH Terms

Interventions

Vaccines, DNA; Biological Products; Vaccines

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Complex Mixtures; Antigens; Biological Factors

Study Officials

• Irene Skjørestad, MSc

  Vaccibody AS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)