None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : BD03 is to be administered intramuscularly total of three times until the end of trial, 6weeks and 2weeks piror to kidney transplant, and 2-4weeks after the trans
Sponsors
SL VaxiGen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability as assessed by dose-limiting toxicities (DLTs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects whose Spot Forming Units per unit PBMC are tripled compared to base line measurements, Fraction of subjects whose Spot Forming Units of each antigen in BD03 /10^6 PBMC are greater than 50.;Proportion of subjects whose CMV DNA copies are greater than 4000copies/mL;Proportion of subjects whose BKV DNA copies are greater than 10000copies/mL.;Incidence of CMV and BKV related disease;Proportion of subjects with preemptive therapy for CMV, Fraction of subjects who undergoes change in immunosuppressant therapy;Antibody response of CMV gB antigen;Antibody response to BKV VP1 antigen;Serum concentration of Flt-3L;Proportion of subjects to whom CMV viremia is observed more than once after kidney transplant.;Proportion of subjects to whom BKV viremia is observed more than once after kidney transplant. | — |
Countries
Korea, Republic of
Contacts
Public ContactChulwoo Yang
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed