Unconfirmed research expenses

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.

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

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).