NCT02596243Unknown2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and the Safety of GX-188E, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation(EP) in HPV Type 16 and/or 18 Positive Patients With Biopsy-proven Cervical Intraepithelial Neoplasia Grade 2(CIN2), Grade 2/3 (CIN2/3), Grade 3(CIN3)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 134
- 试验地点
- 27
- 主要终点
- Number of participants with histopathological regression of cervical lesions to CIN1 or less
研究概览
简要总结
The purpose of this study is to access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 2, 2/3 or 3 (CIN3)
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects age 18-60 years
- •Histologically confirmed HPV-16 or HPV-18 asspcoated CIN2, CIN 2/3 or CIN3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with overall lesion sizes less than 50% of the cervix area and no evidence of invasive cancer in any specimen;
- •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;
- •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 enrolment;
- •For women who are not postmenopausal (at least 12 months of nontherapy- induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period and throughout Week 36 response evaluation visit.
- •Able and willing to comply with all study procedures and voluntarily signs informed consent form.
排除标准
- •Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
- •Pregnancy or breastfeeding;
- •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;
- •History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
- •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 enrollment;
- •Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);
- •Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;
- •Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
- •History of seizures (unless seizure free for 5 years);
- •Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP;
- •Any electronic medical implants (such as cardiac pacemaker);
- •Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
- •A tendency for severe haemorrhage following acute trauma;
- •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;
- •Any other conditions judged by the investigator that would limit the evaluation of a subject.
研究组 & 干预措施
GX-188E
Experimental
GX-188E + EP
干预措施: GX-188E (Biological)
placebo
Placebo Comparator
Placebo + EP
干预措施: Placebo (Biological)
结局指标
主要结局
Number of participants with histopathological regression of cervical lesions to CIN1 or less
时间窗: 36 weeks
The number of participants with cervical lesions regress to CIN1 or less at the 36 week visit
次要结局
- Number of participants with Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN1 or less(36 weeks)
研究者
研究点 (27)
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