A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy based on medical examination/history at the inclusion
- •Age between 18 and 55 years
- •Signed informed consent
- •Prepared to grant authorized persons access to the medical records
- •The volunteer is likely to comply with instructions
排除标准
- •Known exposure to TB before (or expected during) the trial
- •Prior BCG vaccination
- •Granulomatous disease (by chest X-ray, autoimmune screen)
- •Vaccinated with live vaccine 3 months before first vaccination
- •Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
- •HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
- •Participation in other clinical trials
- •Positive Mantoux or QuantiFERON-TB Gold
- •Known hypersensitivity to any of the vaccine components
- •Laboratory parameters outside of normal ranges considered clinically relevant
研究组 & 干预措施
Antigen group + high adjuvans
The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.
干预措施: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a (Biological)
Antigen group
The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.
干预措施: 50 microgram antigen (Ag85B + ESAT-6) (Biological)
Antigen + low adjuvans group
The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.
干预措施: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a (Biological)
结局指标
主要结局
Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.
时间窗: From the first vaccination until 8 months after the first vaccination
次要结局
- Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.(From first vaccination until 36 months after first vaccination)