An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
研究概览
简要总结
The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Has signed an informed consent
- •Is willing and likely to be able to comply with the trial procedures
- •Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
- •Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
- •Is prepared to grant authorized persons access to their medical records
排除标准
- •Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
- •Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
- •Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
- •Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
- •Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
- •Has a known congenital or acquired immune deficiency
- •Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
- •Is known to be infected with HIV, HBV or HCV
- •Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
- •Has a C-reactive protein (CRP) level > 50 mg/L
- •Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
- •Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
- •Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
- •Is pregnant according to urine pregnancy test at inclusion
- •Is a female not willing to use contraceptives or is breastfeeding
- •Has a condition which in the opinion of the investigator is not suitable for participation in the study
研究组 & 干预措施
A
two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval)
干预措施: rdESAT-6 + rCFP-10 (Biological)
B
two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval)
干预措施: rdESAT-6 + rCFP-10 (Biological)
C
two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval)
干预措施: rdESAT-6 + rCFP-10 (Biological)
D
two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval)
干预措施: rdESAT-6 + rCFP-10 (Biological)
E
one injection 1.0 µg rdESAT-6 + rCFP-10
干预措施: rdESAT-6 + rCFP-10 (Biological)
结局指标
主要结局
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
时间窗: onset between the first injection and 28 days after the second injection
次要结局
- The diameter of induration at the second injection site measured transversely to the long axis of the forearm(72 hours after the second injection)