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Safety and Immunogenicity Study of GX-70 in TB Patient

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ClinicalTrials.gov Identifier: NCT03159975
Recruitment Status : Withdrawn (Unconfirmed research expenses)
First Posted : May 19, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculoses High Risk Factors for Relapse Treatment Failure Drug: GX-70 by electroporation Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
  1. Dose level 1 : GX-70 0.26mg
  2. Dose level 2 : GX-70 1mg
  3. Dose level 3 : GX-70 4mg
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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

Experimental: Dose level 2 (GX-70 1mg)
Administrating GX-70 1mg
Drug: GX-70 by electroporation
Gx-70 1mg 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 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times




Primary Outcome Measures :
  1. MTD (Maximum Tolerant Dose) [ Time Frame: Every 4 weeks up to 16 weeks ]

Secondary Outcome Measures :
  1. IFN-γ (SFC/106 cells) [ Time Frame: Every 8 weeks up to 24 weeks ]
    IFN-γ response stimulated by TB antigens

  2. Flt3L concentration (pg/ml) [ Time Frame: Every 8 weeks up to 24 weeks ]
    Every 8 weeks up to 24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   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).
Accepts Healthy Volunteers:   No
Criteria

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

Additional Information:
Publications of Results:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03159975     History of Changes
Other Study ID Numbers: 4-2016-1144
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yonsei University:
Tuberculosis
DNA vaccine
Electroporation
GX-70

Additional relevant MeSH terms:
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Tuberculosis
Recurrence
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections