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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-27

Study Completion Date

2019-07-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM

NCT00370006

Cytomegalovirus Infection

COMPLETED PHASE1

A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

NCT03170609

Group B Streptococcal Infections

COMPLETED PHASE2

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

NCT03036930

Human Papillomavirus Infection Human Papillomavirus-Related Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19

NCT05083039

Coronavirus Infections Vaccine Polio

COMPLETED

Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge

NCT00373412

Cytomegalovirus Infection

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

BD03

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BD03

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No