The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study - Immunotherapy in CINI/ Pap2

eids Universitair Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

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•- patiënts 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 I or cytological evidence of a persistent PAP II (two consecutive pap II smears with a 6 month interval)
•- 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

•- 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

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