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)

VACCIBODY A.S.0 sites34 target enrollmentFebruary 24, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2015

End Date

January 17, 2019

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

VACCIBODY A.S.

•1\. Women \=18 years who, after counselling by their clinicians consider the risk to future pregnancies from treating cervical abnormalities to outweigh the risk of developing cancer during observation of those abnormalities. In this context no specific upper age threshold is intended at the time of clinical trial entry.
•2\. Women with ectocervical HPV16\+ associated High Grade Cervical Intraepithelial Neoplasia as verified by local pathology (biopsy) obtained within four weeks prior to start of treatment.
•2\.1\. Dosing Phase: Women with histologically confirmed HPV16\+ associated CIN 2 high grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2\).
•2\.2\. Expansion Phase: Women with histologically confirmed HPV16\+ associated CIN 2/3 high grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2/3\).
•3\. Satisfactory colposcopic examination documented with colpo\-photography (digital Photography) defined as:
•3\.1\. Visibility of the entire transformation zone including the squamocolumnar junction.
•3\.2\. Visibility of the entire lesion margin.
•4\. ECOG performance status \= 1\.
•5\. Written informed consent.
•6\. Has agreed to the mandatory biological sampling schedule in the study.

•Concomitant conditions
•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, with exception of adequately treated basal cell carcinoma or other non\-melanomatous skin cancer, low grade bladder cancer or other malignancies treated with curative intent 2 or more years pre study entry and in remission at study entry.
•7\. Clinically significant autoimmune disease.
•8\. Known allergy to Kanamycin or other aminoglycosides
•9\. Known immunodeficiency and or immunosuppression.