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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- MTD (Maximum Tolerant Dose)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
- •Adults between 19 and 65 years.
- •TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR
- •TB patients who satisfy following conditions: cavity spotted from chest imaging before TB therapy, positive on AFB smear 2 months after TB therapy.
排除标准
- •At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.
- •If positive on AFB smear is resulted from dead MTB
- •Serious TB such as tuberculous encephalomeningitis
- •Patients with serious pulmonary symptom except TB
- •Patients show poor vital sign considered to be difficult to participate
- •Patients with heart, renal, or liver failure
- •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.
- •When thickness of skin around deltoid muscle which is to be injected exceeds 40mm
- •Patients with QTc prolongation on 12-lead ECG
- •Patients with a cardiac device (such as a pacemaker)
- •Patients that the researchers do not think fit into the group, including patients failed in compliance assessment
研究组 & 干预措施
Dose level 2 (GX-70 1mg)
Administrating GX-70 1mg
干预措施: GX-70 by electroporation (Drug)
Dose level 3 (GX-70 4mg)
Administrating GX-70 4mg
干预措施: GX-70 by electroporation (Drug)
Dose level 1 (GX-70 0.26mg)
Administrating GX-70 0.26mg
干预措施: GX-70 by electroporation (Drug)
结局指标
主要结局
MTD (Maximum Tolerant Dose)
时间窗: Every 4 weeks up to 16 weeks
次要结局
- Flt3L concentration (pg/ml)(Every 8 weeks up to 24 weeks)
- IFN-γ (SFC/106 cells)(Every 8 weeks up to 24 weeks)