NCT00922363已完成1 期
An Open Phase I, Dose-escalating, Clinical Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two doses with two months interval.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male adult between 18 and 55 years of age
- •Healthy according to medical history and medical examinations at screening
- •Signed informed consent
- •Prepared to grant authorized persons access to medical records
- •Likely to comply with instructions
排除标准
- •History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial
- •Positive Tuberculin Skin Test (TST) result at screening
- •Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening
- •BCG vaccination any time before entering the trial
- •History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction
- •Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
- •ANA-Titer, HBV, HCV, HIV sero-positive at screening
- •C-reactive protein level > 50 mg/L at screening
- •Clinically significant abnormal laboratory test results at screening as assessed by the investigator
- •Severe ongoing viral or bacterial infection that might affect the cell mediated immune response
- •A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- •Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination
- •Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination
- •Known hypersensitivity to any of the vaccine components of the investigational vaccines
- •Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen
- •Pregnant according to a urine pregnancy test at inclusion
- •Females not willing to use contraceptives or breast feeding
- •Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial
结局指标
主要结局
Adverse events
时间窗: one year after first vaccination
次要结局
- Immunogenicity(one year after the first vaccination)
研究者
研究点 (2)
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