Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Immunogenicity of neoantigen-primed DC Vaccines
研究概览
简要总结
To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.
详细描述
Cervical cancer is the second most common cause of cancer-related deaths among women worldwide with 10000 new cases each year in China. The high-risk human papillomavirus (HPV) was the major cause of cervical cancer. The oncoproteins E6 and E7 encoded by HPV16 and 18, are consistently expressed in HPV-associated Cervical cancer and are responsible for the cervical cancer malignant progression. Targeting the E6/E7 proteins could be very helpful to regress the CIN 1/2 and block the tumorigenesis.
By this research, we aim to establish the HPV16/18 E6/E7 peptide library which could induce the strong anti-virus immune response and to vaccinate the CIN 1/2 patients with dendritic cell vaccines loaded HPV 16/18 E6/E7 epitopes.
Including:
- To create an effective HPV 16/18 E6/E7 antigen peptide library using NetMHCspan software based on the MHC-I subtype of the Chinese population and screen E6/E7protein peptides with high binding affinity to MHC molecules;
- To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
- The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
- To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years ≤ 70 years at the time of informed consent
- •HPV type 16/18 positive
- •Pathologically confirmed CIN1/2 and no other cervical disease
- •adequate organ functions.
排除标准
- •Severe allergy to drugs
- •Women of child-bearing potential who are pregnant or breast-feeding
- •Any form of primary immunodeficiency
- •With serious cardiac, cerebrovascular and primary diseases
- •With a history of severe mental illness
研究组 & 干预措施
Vaccinated group
Patients will be vaccinated with autologous mature dendritic cells-loaded with HPV 16/18 E6/E7, DC vaccine will be injected into the adjacent lymph-node 6 times, once a week.
干预措施: Vaccinated group (Biological)
结局指标
主要结局
Immunogenicity of neoantigen-primed DC Vaccines
时间窗: once per three month
Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: 3 months after the last vaccination injection
Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
次要结局
- Objective Response Rate(once per three month)