NL-OMON31758已完成2 期
The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study - Immunotherapy in CIN II-III
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- patients of 18 years and older
- •- willing and able to comply with the protocol, and provide informed consent in accordance with institutional and regulatory guidelines
- •- histological evidence of CIN, grade II or III, HPV16 positive
- •- performance status 1 or 2 at the WHO scale, or 60 on the Karnofsky scale
- •- baseline laboratory findings; white blood cells (WBC) > 3,000 x 10 9/l, lymphocytes >1,000 x 10 9/l, platelets > 100 x 10 9/l, and hematocrit > 30%, HIV- and HBV-negative
- •- patients of child-bearing potential should test negative using a pregnancy test and agree to utilize effective contraception or remain abstinent during the entire treatment period of the study
排除标准
- •- indication of a current active infectious disease other than HPV16,
- •- history of an autoimmune disease or other systemic intercurrent disease that might affect patient*s immunocompetence
- •- history of a second malignancy except curatively treated low-stage tumours with a histology that can be differentiated from the vulvar/cervical cancer type
- •- radiotherapy, chemotherapy or other potentially immunosuppressive therapy administered within 4 weeks prior to the colposcopy visit
研究者
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