Title
Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient
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
Phase
Phase 1Lead Sponsor
SL BIGENStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Preventation of Cytomegalovirus Reactivation BK Virus Infection Preventation of BK Virus Reactivation ...Intervention/Treatment
BD03Study Participants
18This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) for the BD03 vaccination in kidney transplant recipients. The recommended dose will be selected based on the safety and tolerability profiles observed.
It is reported that CMV and BKV infection and/or reactivations are associated with mortality and morbidity of kidney transplant recipient, and occurrence of PyVAN in kidney transplant recipients.
BD03 is a DNA vaccine that consists of 3 plasmid DNAs encoding CMV antigens, BKV antigens and genetic adjuvant. It is expected to express antigen specific T-cell immune response, and ultimately prevent activation of both viruses. Plasmid DNA that encode CMV and BKV antigens are fused with tPA and Flt-3L to promote antigen specific immune response.
Patient scheduled to receive kidney transplant from living donor are enrolled in this study. Eligible subjects will receive BD03 intramuscularly by electroporator three times on 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.
This study will be comprised of 3+3 dose escalation scheme and starting dose is 0.6mg and dose will be increased to 2mg and 6mg.
Occurrence of dose limiting toxicities observed until 1 week after second injection (1week before kidney transplant) will guide whether to increase a dose.
After third injection of BD03, follow up visits are done for 18 weeks.
This study will be comprised of 3+3 dose escalation design with three dose levels, 0.6mg (cohort1), 2mg(cohort2), 6mg(cohort3). Decision to increase dose will be guided by occurrence of DLT (dose limiting toxicity) evaluated 1week after the second injection (5weeks after first injection)
Inclusion Criteria: Age of ≥ 19 Body Mass Index ≤ 35 Weight ≥ 40kg Exclusion Criteria: CMV IgG seronegative patient Patient scheduled for retransplant of kidney Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Patient expected to receive T-cell depleting agents or rituximab Patient with history of splenectomy 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. Patient expected to undergo CMV prophylaxis using anti-virals or immunoglobulins. Patient who has hypersensitivity to BD03 or components of BD03. Patient with history of epilepsy or seizure with the last 2 years Patients with pre-excitation syndrome or any other disease who would be considered ineligible for electroporation injection. Patient with blood coagulation disorder who would be considered ineligible for electroporation injection Patient with injection site thickness greater than 40mm Patient with artificial implant near injection site Pregnant or breast-feeding female patient Female subject or partner of male subject with child bearing potential and who has not agreed to sexual abstinence Patient who has participated in any other clinical trial within 30 days Patient who has any clinically meaningful disease investigator's judgement to prevent participating in this study
