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

NCT03576014 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-03

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

BD03

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

Sponsors & Collaborators

  • SL BIGEN

    collaborator UNKNOWN

  • SL VAXiGEN

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2019-01-30
Completion
2019-07-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576014 on ClinicalTrials.gov