KCT0000284撤回未知
PHASE II PLACEBO-CONTROLLED STUDY OF VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA VACCINE) DELIVERED IM FOLLOWED BY ELECTROPORATION (EP) WITH CELLECTRA®-5P FOR THE TREATMENT OF BIOPSY-PROVEN CIN 2/3 OR CIN 3 WITH DOCUMENTED HPV 16 OR 18
Inovio0 个研究点目标入组 148 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 55(Year)（—）
- 性别
- Female
入选标准
- •a.Female subjects age 18-55 years;
- •b.Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from a biopsy less than 8 weeks prior to Vaccination/EP #1 with no evidence of invasive cancer in any specimen;
- •c.Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; lesions in = 3 cervical quadrants;
- •d.Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrollment and administration of study drug;
- •e.Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);
- •f.Able and willing to comply with all study procedures and voluntarily signs informed consent form
排除标准
- •a.Colposcopy is unsatisfactory AND an endocervical curette (ECC) specimen identifies endocervical CIN that is not directly visualized and therefore not amenable to adequate colposcopic follow-up evaluations;
- •b.Pregnancy or breastfeeding;
- •c.Immunosuppression including any concurrent condition requiring 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. All other corticosteroids must be discontinued >4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
- •d.History of previous therapeutic HPV vaccination;
- •e.Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);
- •f.Administration of any blood product within 3 months of enrollment;
- •g.Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine)
- •h.Participation in a study with an investigational compound or device within 30 days of signing informed consent;
- •i.Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
- •j.History of seizures (unless seizure free for 5 years);
- •k.Tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination/EP or any subject who has implanted metallic material;
- •l.Subjects who have a history of severe allergic reaction or hypersensitivity reaction;
- •m.Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
- •n.Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
- •o.Any other conditions judged by the investigator that would limit the evaluation of a subject.
研究者
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