Pulmonary Tuberculoses Clinical Trial
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
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.
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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