NCT03159975

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

May 14, 2017

Last Update Submit

January 9, 2019

Conditions

Pulmonary TuberculosesHigh Risk Factors for RelapseTreatment Failure

Keywords

TuberculosisDNA vaccineElectroporationGX-70

Outcome Measures

Primary Outcomes (1)

  • MTD (Maximum Tolerant Dose)

    Every 4 weeks up to 16 weeks

Secondary Outcomes (2)

  • IFN-γ (SFC/106 cells)

    Every 8 weeks up to 24 weeks

  • Flt3L concentration (pg/ml)

    Every 8 weeks up to 24 weeks

Study Arms (3)

Dose level 1 (GX-70 0.26mg)

EXPERIMENTAL

Administrating GX-70 0.26mg

Drug: GX-70 by electroporation

Dose level 2 (GX-70 1mg)

EXPERIMENTAL

Administrating GX-70 1mg

Drug: GX-70 by electroporation

Dose level 3 (GX-70 4mg)

EXPERIMENTAL

Administrating GX-70 4mg

Drug: GX-70 by electroporation

Interventions

GX-70 by electroporationDRUG

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

Dose level 1 (GX-70 0.26mg)

Eligibility Criteria

Age19 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAbility 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).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 11401954RESULT

  • 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.

    PMID: 15374844RESULT

  • 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.

    PMID: 21956689RESULT

MeSH Terms

Conditions

Tuberculosis, PulmonaryTuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 1. Dose level 1 : GX-70 0.26mg 2. Dose level 2 : GX-70 1mg 3. Dose level 3 : GX-70 4mg
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 19, 2017

Study Start

March 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share