EUCTR2012-001334-33-EE进行中（未招募）不适用
PHASE II PLACEBO-CONTROLLED STUDY OF VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA VACCINE) DELIVERED IM FOLLOWED BY ELECTROPORATION (EP) WITH CELLECTRA®-5P FOR THE TREATMENT OF BIOPSY-PROVEN CIN 2/3 OR CIN 3 WITH DOCUMENTED HPV 16 OR 18
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •a. Female subjects age 18-55 years;
- •b. Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive
- •cancer in any specimen;
- •c. Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; lesions in = 3 cervical quadrants (4 quadrant disease where the lesion occupies less than 50% of each quadrant will be considered for inclusion);
- •d. Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrollment and administration of study drug;
- •e. Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);
- •f. Able and willing to comply with all study procedures and voluntarily signs informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 148
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
- •b. Pregnancy or breastfeeding;
- •c. Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
- •d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
- •e. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);
- •f. Administration of any blood product within 3 months of enrollment;
- •g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);
- •h. Participation in a study with an investigational compound or device within 30 days of signing informed consent;
- •i. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
- •j. History of seizures (unless seizure free for 5 years);
- •k. Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads;
- •l. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
- •m. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
- •n. Any other conditions judged by the investigator that would limit the evaluation of a subject.
研究者
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