NCT03206138Unknown不适用
A Randomized, Open-label Study to Evaluate the Safety and Efficacy of GX-188E, a DNA Therapeutic Vaccine Administered Intramuscularly by Electroporation, With GX-I7 Intravaginal Application or Imiquimod Topical Application in HPV16 and/or 18 Positive Patients With CIN3.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
研究概览
简要总结
This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.
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
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- •Female subjects age 19-50 years.
- •HPV 16 and/or 18 positive.
- •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
- •Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3.
排除标准
- •Pregnancy or breastfeeding
- •History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded).
- •Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- •Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.
研究组 & 干预措施
GX-188E, GX-I7
Experimental
GX-188E + GX-I7
干预措施: GX-188E, GX-I7 (Biological)
GX-188E, Imiquimod
Experimental
GX-188E + Imiquimod
干预措施: GX-188E, Imiquimod (Biological)
结局指标
主要结局
Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.
时间窗: at week 20
次要结局
- Ratio of subjects with clearance of HPV 16 or 18 and histopathological regression of cervical lesions to CIN 1 or less.(at week 20, and week 36)
- The change of cytology of uterine cervix compared to baseline.(at screening, week 12, week 20, and week 36)
- Flt-3L concentrations in blood samples.(at week 14, week 20, and week 36.)
研究者
Jongsup Park
Professor
Seoul St. Mary's Hospital
研究点 (1)
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