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
1 other identifier
interventional
18
1 country
2
Brief Summary
This 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2018
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2019
CompletedJuly 3, 2018
May 1, 2018
9 months
May 25, 2018
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability as measured by dose-limiting toxicities (DLTs)
An event will be considered a DLT if the event is reasonably related to study treatment during the 5weeks of treatment, and meets the following criteria: Any Grade 3 or greater toxicity per CTCAE 4.03 that would be considered dose-limiting except for those associated with kidney failure, Grade 3 or greater Creatine kinase increase that is not accompanied with Rhabdomyolysis, and any other Grade3 or greater toxicity that exists before participation of this study.
5 weeks
Secondary Outcomes (4)
Proportion of subjects whose Spot Forming Units per unit PBMC are tripled compared to base line measurements and subjects whose Spot Forming Units of each antigen in 10^6 PBMC are greater than 50.
Up to 30 weeks post-dose
Antibody response to CMV gB antigen
Up to 30 weeks post-dose
Antibody response to BKV VP1 antigen
Up to 30 weeks post-dose
Change of CMV and BKV plasma viral load over time
Up to 30 weeks post-dose
Study Arms (1)
BD03
EXPERIMENTALThis 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)
Interventions
BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2\~4 weeks after the transplant.
Eligibility Criteria
You may qualify if:
- Age of ≥ 19
- Body Mass Index ≤ 35
- Weight ≥ 40kg
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SL VAXiGENlead
- SL BIGENcollaborator
Study Sites (2)
Samsung Medical center
Seoul, 06351, South Korea
Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Related Publications (2)
Hirsch HH, Randhawa P; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation. Am J Transplant. 2013 Mar;13 Suppl 4:179-88. doi: 10.1111/ajt.12110.
PMID: 23465010BACKGROUNDKidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
PMID: 19845597BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
July 3, 2018
Study Start
April 27, 2018
Primary Completion
January 30, 2019
Study Completion
July 24, 2019
Last Updated
July 3, 2018
Record last verified: 2018-05