NCT03141463已完成1 期
Immune Modulating Effects and Safety of Vvax001, a Therapeutic Semliki Forest Virus Based Cancer Vaccine, in Patients With a History of (Pre) Malignant Cervical Lesions.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Immunogenicity
研究概览
简要总结
Immune modulating effects and safety of Vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.
详细描述
Vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A history of CIN II and III OR cervical cancer
- •Minimally 12 weeks after completion of treatment
- •Age of 18 years and older
- •Baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, HIV- and HBV-negative
- •Patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study
- •Written informed consent according to local guidelines
排除标准
- •Prior treatment with immunotherapeutic agents against HPV
- •History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy.
- •History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type
- •Participation in a study with another investigational drug within 30 days prior to the enrolment in this study
- •Any condition that in the opinion of the investigator could interfere with the conduct of the study
研究组 & 干预措施
Vvax001 therapeutic cancer vaccine
Experimental
Patients will receive three consecutive doses of Vvax001, with an interval of 3 weeks
干预措施: Vvax001 therapeutic cancer vaccine (Biological)
结局指标
主要结局
Immunogenicity
时间窗: Day 28-31 and day 49-52 after first administration of Vvax001
To assess the immunological activity of Vvax001 by monitoring HPV-16 E6,7-specific T-cell immune responses
次要结局
- Number of treatment-related adverse events as assessed by CTCAE v4.0(up to 49-52 days after first administration of Vvax001)
研究者
Refika Yigit
MD PhD
University Medical Center Groningen
研究点 (2)
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