Evaluate Tolerability and Safety of BD03 for Prevention of CMV and BKV Reactivation in Kidney Transplant Recipient

June 21, 2018 updated by: SL VAXiGEN

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Sungjoo Kim, M.D, Ph.D
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Seoul St.Mary's Hospital
        • Contact:
          • Chulwoo Yang, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BD03

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)
Biological: BD03
BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability as measured by dose-limiting toxicities (DLTs)
Time Frame: 5 weeks
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 Outcome Measures

Outcome Measure
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.
Time Frame: Up to 30 weeks post-dose
To evaluate the immunogenicity of BD03. ELISPOT assay of specific T cell responses to CMV and BKV antigens.
Up to 30 weeks post-dose
Antibody response to CMV gB antigen
Time Frame: Up to 30 weeks post-dose
To investigate antibody level measured by Enzyme-Linked ImmunoSorbent Assay(ELISA)
Up to 30 weeks post-dose
Antibody response to BKV VP1 antigen
Time Frame: Up to 30 weeks post-dose
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
Time Frame: Up to 30 weeks post-dose
To investigate change of CMV and BKV plasma viral load over time
Up to 30 weeks post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SL VAXiGEN

Collaborators

SL BIGEN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2018

Primary Completion (Anticipated)

January 30, 2019

Study Completion (Anticipated)

July 24, 2019

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

July 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD03_KT_P1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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