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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
MTD (Maximum Tolerant Dose)
Time frame: Every 4 weeks up to 16 weeks
IFN-γ (SFC/106 cells)
IFN-γ response stimulated by TB antigens
Time frame: Every 8 weeks up to 24 weeks
Flt3L concentration (pg/ml)
Every 8 weeks up to 24 weeks
Time frame: Every 8 weeks up to 24 weeks
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