NCT03576014

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: SL VAXiGEN · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cytomegalovirus Infections
• Preventation of Cytomegalovirus Reactivation
• BK Virus Infection
• Preventation of BK Virus Reactivation

Interventions

Type	Name	Description
BIOLOGICAL	BD03	BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2\~4 weeks after the transplant.

Timeline

• Start date: 2018-04-27
• Primary completion: 2019-01-30
• Completion: 2019-07-24
• First posted: 2018-07-03
• Last updated: 2018-07-03

Locations

2 sites across 1 country: South Korea