Safety and Immunogenicity Study of GX-70 in TB Patient

January 9, 2019 updated by: Yonsei University

A Open-label, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Tolerability, Safety and Immunogenicity of GX-70, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Patients With Pulmonary Tuberculosis Who Have High Risk Factors for Relapse or Treatment Failure

The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Tuberculosis still matters in domestic as well as global public health. According to WHO, 8,700,000 cases of tuberculosis occured in 2011, and 1,400,000 of them resulted dead. Tuberculosis patients with the cavity and positive on AFB show high rate of relapse and treatment failure. Those with high risk of relapse and treatment failure may need more effective treatment before acquiring resistance and infecting others. GX-70, which consists of the four-antigen plasmids from MTB together with recombinant Flt3 ligand is an investigational DNA vaccine designed to prevent relapse or treatment failure.

The purpose of this study is to assess safety of GX-70, in pulmonary TB patients with high risk factors for treatment failure or relapse.

Study Type

Interventional

Phase

  • Phase 1

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
  2. Adults between 19 and 65 years.
  3. TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR
  4. TB patients who satisfy following conditions: cavity spotted from chest imaging before TB therapy, positive on AFB smear 2 months after TB therapy.

Exclusion Criteria:

  1. At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.
  2. If positive on AFB smear is resulted from dead MTB
  3. Serious TB such as tuberculous encephalomeningitis
  4. Patients with serious pulmonary symptom except TB
  5. Patients show poor vital sign considered to be difficult to participate
  6. Patients with heart, renal, or liver failure
  7. Patients with infection, ulcer, edema, tattoo, scar, wound and other conditions in skin around 3cm of deltoid muscle that result inappropriate to inject through electroporation.
  8. When thickness of skin around deltoid muscle which is to be injected exceeds 40mm
  9. Patients with QTc prolongation on 12-lead ECG
  10. Patients with a cardiac device (such as a pacemaker)
  11. Patients that the researchers do not think fit into the group, including patients failed in compliance assessment

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1 (GX-70 0.26mg)
Administrating GX-70 0.26mg
Drug: GX-70 by electroporation
Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Experimental: Dose level 2 (GX-70 1mg)
Administrating GX-70 1mg
Drug: GX-70 by electroporation
Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Experimental: Dose level 3 (GX-70 4mg)
Administrating GX-70 4mg
Drug: GX-70 by electroporation
Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Drug: GX-70 by electroporation
Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD (Maximum Tolerant Dose)
Time Frame: Every 4 weeks up to 16 weeks
Every 4 weeks up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IFN-γ (SFC/106 cells)
Time Frame: Every 8 weeks up to 24 weeks
IFN-γ response stimulated by TB antigens
Every 8 weeks up to 24 weeks
Flt3L concentration (pg/ml)
Time Frame: Every 8 weeks up to 24 weeks
Every 8 weeks up to 24 weeks
Every 8 weeks up to 24 weeks

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-1144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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