A Single Center, Phase I Study to Follow-up on the Change of Immunogenicity and Lesion Condition in Subjects Who Have Completed the Phase I GX-188E Trial (Protocol no. GX-188E-SN)
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The change of the immune response compared to that of the final visit in phase I study
研究概览
简要总结
This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.
详细描述
This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and completed GX-188E phase I study.
Subjects will make visits at week 48 (V1) to week 228 (V8) every 6 months after the final administration of GX-188E.
The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase I study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 20 and 50 (inclusive)
- •The subjects who have visited within 48 weeks after final injection of GX-188E
- •Those who voluntarily signed informed consent form
排除标准
- •Prior participation in any clinical trial within 30 days prior to the visit 1
- •Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
结局指标
主要结局
The change of the immune response compared to that of the final visit in phase I study
时间窗: at week 0 to 180 every 6 months
It would be determined by evaluating HPV type 16/18 E6 and E7 specific T cell response (IFN-γ ELISPOT assay) using PBMC obtained at week 0 to 180 visit every 6 months.
次要结局
- The change of the involved lesion and HPV infection status(at week 0 to 180 every 6 months)
- Safety profile(at week 0 to 180 every 6 months)