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| Name | Class |
|---|---|
| SL BIGEN | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BD03 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD03 | Biological | BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | To evaluate the immunogenicity of BD03. ELISPOT assay of specific T cell responses to CMV and BKV antigens. | Up to 30 weeks post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujin Kim, Ph.D | Contact | 031-628-2182 | sjkim@slvaxigen.com | |
| Mincheol Kim | Contact | 031-628-2182 | mckim@slvaxigen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23465010 | Background | 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. | |
| 19845597 | Background | Kidney 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. |
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| Antibody response to CMV gB antigen |
To investigate antibody level measured by Enzyme-Linked ImmunoSorbent Assay(ELISA) |
| Up to 30 weeks post-dose |
| Antibody response to BKV VP1 antigen | To investigate antibody level measured by Enzyme-Linked ImmunoSorbent Assay(ELISA) | Up to 30 weeks post-dose |
| Change of CMV and BKV plasma viral load over time | To investigate change of CMV and BKV plasma viral load over time | Up to 30 weeks post-dose |
| Seoul St.Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
|
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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