NCT05905354招募中不适用
Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
Newish Technology (Beijing) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.
研究概览
简要总结
This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.
详细描述
The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.The secondary objective was to observe the safety of NWRD08 in cervical patients who were positive for HPV16 and/or HPV18, and to initially explore the efficacy of NWRD08.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Age ≥18 years old;
- •women who have sex;
- •HPV16 and/or 18 DNA and E6E7 mRNA were positive;
- •Patients with highly squamous intraepithelial lesions of the cervix confirmed by histology and cytology, or persistent cervical PV16 and/or 18 infection for more than 12 months;
- •Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
- •Electrocardiogram (ECG) is normal;
- •Women of reproductive age must have a negative serum pregnancy test within 1 week prior to the first dose and have agreed to use effective contraception during the study drug use period and within 6 months after the last dose of the study drug. For males, it should be surgical sterilization or consent to effective contraception during the study drug use period and within 6 months after the last study drug administration;
- •Have fully understood the study and voluntarily signed the ICF, be able to communicate well with the investigator and complete all treatments, examinations and visits required by the study protocol.
排除标准
- •any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
- •Patients with unsatisfactory colposcope;
- •Patients who were satisfied with colposcopy but not satisfied with ECC (patients who were positive for HPV18 or had abnormal adenocytes on cervical cytology but satisfied with colposcopy should undergo ECC examination);
- •Positive HPV type 31 or 33 or 45 or 52 or 58;
- •Have received cervical physical therapy;
- •pregnant, breastfeeding, or considering becoming pregnant during the study period;
- •previous history of therapeutic or preventive HPV vaccination;
- •Received any non-investigational inactivated vaccine injection within 2 weeks;
- •Received any non-investigational live vaccine within 4 weeks;
- •Acute or chronic bleeding or coagulopathy;
- •Less than two sites can be used for intramuscular injection;
- •Received chemotherapy, molecular targeted therapy, biological immunotherapy, or Chinese patent drugs for cervical lesions within 30 days before or during screening;
- •participated in other clinical trials within 30 days prior to screening, or was in the observation period of other clinical trials;
- •Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone > 10 mg/ day), except hormone replacement therapy and endotracheal administration;
- •History of immune deficiency or autoimmune disease (such as rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
- •with uncontrolled severe infection;
- •Patients with a history of hepatitis B virus (HBV), hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection or syphilis carriers;
- •Patients with severe other organ dysfunction or cardiopulmonary disease, including myocardial infarction, stroke, congestive heart failure, severe lung disease, metabolic diseases, wound healing abnormalities, ulcers or fractures;
- •Epilepsy accompanied by medication (such as steroids or antiepileptic drugs);
- •Previous or present malignant neoplasms;
- •A history of severe allergies, or a history of allergic diseases, or an allergic constitution, or a severe iodine contrast allergy, meeting any of these criteria;
- •serious mental disorders;
- •A history of drug or alcohol abuse;
- •A pregnant or lactating woman, or a woman of childbearing age who has a positive blood pregnancy test, or a patient of childbearing age and her spouse who is unwilling to take effective contraceptive measures during the clinical study period and within 6 months after the end of treatment;
- •Patients deemed unsuitable for this clinical trial by the investigator.
结局指标
主要结局
HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.
时间窗: Week36
Analysis of immunogenicity data included the level, type, subtype, and time and duration of specific humoral and cellular immune responses in peripheral blood before and after vaccination.
次要结局
- proportion of patients with regression of cervical lesions(Week 36)
- proportion of patients with HPV virus clearance(Week 36)
- Adverse Events (AEs)(End of study)
研究者
研究点 (1)
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