Discovery of HPV T Cell Epitopes and Development of Multi-epitope Vaccines
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The activity of T cell
研究概览
简要总结
Based on the trend that the incidence and mortality of cervical carcinoma among female cancers worldwide are increasing year by year, the investigators aim to develop a multi-epitope therapeutic vaccine capable of simultaneously activating humoral and cellular immune responses, which is achieved by fusing multiple T-cell epitope immunostimulatory proteins. To obtain information on functional T-cell epitopes to be included in the vaccine, the investigators conducted research starting from clinical cases. By collecting peripheral blood and cancerous tissues from clinical patients, the investigators isolated reactive T-cells and screened for information on T-cell epitopes of HPV antigens.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged between 18 and 65 who can receive standard treatment, including those who only undergo surgery or those who receive radiotherapy and chemotherapy after surgery.
- •Cervical carcinoma caused by HPV16 or HPV18 infection.
- •The pathological stage is from IB1 to IV, and informed consent is obtained.
- •If the tumor tissue of patients with stage IB1 is not obvious, samples can be taken or not taken without affecting subsequent pathological examinations.
排除标准
- •Patients with other malignancies
- •Patients with any uncontrolled systemic disease, including active infection, uncontrolled hypertension, diabetes mellitus, unstable angina and congestive heart failure, myocardial infarction (1 year) before starting treatment, severe arrhythmia requiring medical treatment, coagulation abnormalities, liver or kidney or metabolic disease.
结局指标
主要结局
The activity of T cell
时间窗: one month
The T cell activity exceeds 95%.
次要结局
未报告次要终点
