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Safety and Immunogenicity Study of GX-70 in TB Patient

Primary Purpose

Pulmonary Tuberculoses, High Risk Factors for Relapse, Treatment Failure

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

GX-70 by electroporation

About this trial

This is an interventional prevention trial for Pulmonary Tuberculoses focused on measuring Tuberculosis, DNA vaccine, Electroporation, GX-70

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
Adults between 19 and 65 years.
TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR
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:

At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.
If positive on AFB smear is resulted from dead MTB
Serious TB such as tuberculous encephalomeningitis
Patients with serious pulmonary symptom except TB
Patients show poor vital sign considered to be difficult to participate
Patients with heart, renal, or liver failure
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.
When thickness of skin around deltoid muscle which is to be injected exceeds 40mm
Patients with QTc prolongation on 12-lead ECG
Patients with a cardiac device (such as a pacemaker)
Patients that the researchers do not think fit into the group, including patients failed in compliance assessment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dose level 1 (GX-70 0.26mg)

Dose level 2 (GX-70 1mg)

Dose level 3 (GX-70 4mg)

Arm Description

Administrating GX-70 0.26mg

Administrating GX-70 1mg

Administrating GX-70 4mg

Outcomes

Primary Outcome Measures

MTD (Maximum Tolerant Dose)

Secondary Outcome Measures

IFN-γ (SFC/106 cells)

IFN-γ response stimulated by TB antigens

Flt3L concentration (pg/ml)

Every 8 weeks up to 24 weeks

Full Information

NCT ID

NCT03159975

First Posted

May 14, 2017

Last Updated

January 9, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03159975

Brief Title

Safety and Immunogenicity Study of GX-70 in TB Patient

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Unconfirmed research expenses

Study Start Date

March 2018 (Anticipated)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Tuberculoses, High Risk Factors for Relapse, Treatment Failure

Keywords

Tuberculosis, DNA vaccine, Electroporation, GX-70

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Dose level 1 : GX-70 0.26mg Dose level 2 : GX-70 1mg Dose level 3 : GX-70 4mg

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose level 1 (GX-70 0.26mg)

Arm Type

Experimental

Arm Description

Administrating GX-70 0.26mg

Arm Title

Dose level 2 (GX-70 1mg)

Arm Type

Experimental

Arm Description

Administrating GX-70 1mg

Arm Title

Dose level 3 (GX-70 4mg)

Arm Type

Experimental

Arm Description

Administrating GX-70 4mg

Intervention Type

Drug

Intervention Name(s)

GX-70 by electroporation

Intervention Description

Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times

Intervention Type

Drug

Intervention Name(s)

GX-70 by electroporation

Intervention Description

Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times

Intervention Type

Drug

Intervention Name(s)

GX-70 by electroporation

Intervention Description

Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times

Primary Outcome Measure Information:

Title

MTD (Maximum Tolerant Dose)

Time Frame

Every 4 weeks up to 16 weeks

Secondary Outcome Measure Information:

Title

IFN-γ (SFC/106 cells)

Description

IFN-γ response stimulated by TB antigens

Time Frame

Every 8 weeks up to 24 weeks

Title

Flt3L concentration (pg/ml)

Description

Every 8 weeks up to 24 weeks

Time Frame

Every 8 weeks up to 24 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Ability to avoid pregnancy during the trial: Women physically capable of pregnancy must avoid pregnancy during ongoing period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), or use of acceptable contraception: hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD).

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who voluntarily consented, after listening enough explanation for this study and investigational product. Adults between 19 and 65 years. TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR 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: At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive. If positive on AFB smear is resulted from dead MTB Serious TB such as tuberculous encephalomeningitis Patients with serious pulmonary symptom except TB Patients show poor vital sign considered to be difficult to participate Patients with heart, renal, or liver failure 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. When thickness of skin around deltoid muscle which is to be injected exceeds 40mm Patients with QTc prolongation on 12-lead ECG Patients with a cardiac device (such as a pacemaker) Patients that the researchers do not think fit into the group, including patients failed in compliance assessment

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11401954

Citation

Flynn JL, Chan J. Tuberculosis: latency and reactivation. Infect Immun. 2001 Jul;69(7):4195-201. doi: 10.1128/IAI.69.7.4195-4201.2001. No abstract available.

Results Reference

result

PubMed Identifier

15374844

Citation

Chang KC, Leung CC, Yew WW, Ho SC, Tam CM. A nested case-control study on treatment-related risk factors for early relapse of tuberculosis. Am J Respir Crit Care Med. 2004 Nov 15;170(10):1124-30. doi: 10.1164/rccm.200407-905OC. Epub 2004 Sep 16.

Results Reference

result

PubMed Identifier

21956689

Citation

Ahn SS, Jeon BY, Kim KS, Kwack JY, Lee EG, Park KS, Sung YC, Cho SN. Mtb32 is a promising tuberculosis antigen for DNA vaccination in pre- and post-exposure mouse models. Gene Ther. 2012 May;19(5):570-5. doi: 10.1038/gt.2011.140. Epub 2011 Sep 29.

Results Reference

result

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Safety and Immunogenicity Study of GX-70 in TB Patient

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