KCT0002966招募中未知
A Prospective, Open, Dose-escalation, Multi-center, Phase 1 Trial to Evaluate Tolerability and Safety of Intramuscularly Administered BD03, a DNA vaccine for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
SL VaxiGen0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Patients who sign and date on the written informed consent form
- •2) Age of = 19
- •3) Patients who are scheduled for kidney transplant from living donor
- •4) Weight = 40kg
- •5) Body Mass Index = 35
排除标准
- •1) Kidney transplant recipient who has CMV IgG seronegative
- •2) Patient who is not eligible for kidney transplant according to guideline
- •3) Patient who is scheduled for transplant other than kidney transplant
- •4) Patient who is scheduled for retransplant of kidney
- •5) Patient scheduled for kidney transplant from donor aged 6 or/and below 6 or 70 or/and above 70
- •6) Patient scheduled for kidney transplant from deceased donor
- •7) Known active Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- •8) Patient with medical history of malignant tumor within the last 5 years, excluding basal cell or squamous cell carcinoma not metastasized to skin, CIN or CIS cervical carcinoma, or intraepithelial carcinoma of other area.
- •9) Patient who expects to be received T-cell depleting agents(alemtuzumab, OKT-3, thymoglobulin (ATG), Atgam etc.)
- •10) Patient who expects to be received rituximab
- •11) Patient who had history of splenectomy
- •12) Patient with CMV related disease or shows active CMV infection or who has been treated with CMV related disease or CMV infection within 3 months from consent date.
- •13) Patient who expects to undergo CMV prophylaxis using anti-virals or immunoglobulins.
- •14) Patient who has hypersensitivity to BD03 or components of BD03.
- •15) Patient who does not enough time mentioned on protocol after prohibited medication or therapy
- •16) The patient needs to take concomitant drugs that are prohibited in combination with the investigational product
- •17) Patient with history of epilepsy or seizure with the last 2 years
- •18) Patients with infection, ulcer, edema, tattoo, scar, wound and other conditions in skin around 2cm of injection site who would be considered ineligible for electroporation injection.
- •19) Patient with injection site thickness greater than 40mm
- •20) Patient with artificial implant by orthopedics surgery near injection site
- •21) Patient with electronic implant near injection site
- •22) Sinus bradycardia patient with heart rate below 50
- •23) Patient with pre-excitation syndrome or any other disease who would be considered ineligible for electroporation injection.
- •24) Patient with blood coagulation disorder who would be considered ineligible for electroporation injection
- •25) Pregnant or breast-feeding female patient
- •26) Female subject or partner of male subject with child bearing potential and who has not agreed to sexual abstinence
- •27) Patient who has participated in any other clinical trial within 30 days
- •28) Patient who has any clinically meaningful disease investigator's judgement to prevent participating in this study
研究者
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