NCT03159975

Safety and Immunogenicity Study of GX-70 in TB Patient

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculoses
• High Risk Factors for Relapse
• Treatment Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-05-19
• Last updated: 2019-01-11