Safety and Immunogenicity Study of GX-70 in TB Patient

Phase 1

Withdrawn

• Conditions: Treatment Failure; Pulmonary Tuberculoses; High Risk Factors for Relapse
• Interventions: Drug: GX-70 by electroporation

• Registration Number: NCT03159975
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2018-03
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose level 2 (GX-70 1mg)	GX-70 by electroporation	Administrating GX-70 1mg
Dose level 1 (GX-70 0.26mg)	GX-70 by electroporation	Administrating GX-70 0.26mg
Dose level 3 (GX-70 4mg)	GX-70 by electroporation	Administrating GX-70 4mg

Primary Outcome Measures

Name	Time	Method
MTD (Maximum Tolerant Dose)	Every 4 weeks up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Flt3L concentration (pg/ml)	Every 8 weeks up to 24 weeks	Every 8 weeks up to 24 weeks
IFN-γ (SFC/106 cells)	Every 8 weeks up to 24 weeks	IFN-γ response stimulated by TB antigens