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

NCT02529930 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-07-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Theradex

    collaborator INDUSTRY

  • Vaccibody AS

    collaborator INDUSTRY

  • Nykode Therapeutics ASA

    lead INDUSTRY

Principal Investigators

  • Irene Skjørestad, MSc · Vaccibody AS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02529930 on ClinicalTrials.gov