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 个研究点目标入组 34 人开始时间: 2015年2月24日最近更新: 2019年11月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 34

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 39
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

排除标准

•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.
•10. History of toxic shock syndrome.
•11. Evidence or history of clinically significant cardiac disease including congestive heart failure, unstable angina, acute myocardial infarction or cerebrovascular accident within the last six months, and symptomatic arrhythmia requiring therapy (with the exception of extra systoles or minor conduction abnormalities and controlled and well treated chronic atrial fibrillation).
•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.
•Current and prior treatment
•14. Immunosuppression including the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents for any concurrent condition. All other corticosteroids must be discontinued > 4 weeks prior to first study vaccine administration.
•15. Major surgery within 3 months of trial entry.
•16. Current or recent (within 30 days of the first study treatment) participation in a clinical trial or treatment with another investigation medicinal product.
•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.
•Haematology, coagulation and biochemistry:
•20. Inadequate bone marrow function:
•20.1. Absolute Lymphocyte count: < 0.8 x 10^9/L.
•20.2. Platelet count <100 x 10^9/L or haemoglobin <6 mmol/L (transfusion allowed up to 12 weeks prior to screening).
•21. Inadequate liver function:
•21.1. Serum total bilirubin >1.5 x the Upper Limit of Normal (ULN) for the institution.
•21.2. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) >3.0 x ULN.
•21.3. Alkaline phosphatase levels >5.0 x ULN.
•22. Clinically significant uncorrected electrolyt

研究者

发起方

VACCIBODY A.S.

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