NCT01798095Unknown2 期
A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Determination of similarity in responses
研究概览
简要总结
Determine if investigational products and reference standard produce similar responses.
详细描述
Primary:
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.
Secondary:
- To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb;
- To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or nonpregnant females, age 18 to 70 years
- •Negligible risk of manifesting a positive PPD test as evidenced by:
- •Prior history of negative PPD test or interferon gamma release assay (IGRA) within 14 months before Screening
- •No history of Bacillus Calmette- Guérin vaccination; or if vaccination status is uncertain, was born in the US and did not live outside the US as a child
- •No history of Mtb or Mtb therapy (including isoniazid, rifampin, ethambutol, pyrazinamide, or streptomycin)
- •No history of infection with atypical mycobacteria, including suspicious chest roentgenogram
- •No history of high risk medical conditions (eg, HIV infection or other immunosuppressive conditions, severe chronic renal disease [as evidenced by a creatinine clearance < 30 ml/min], poorly controlled diabetes mellitus, silicosis, intravenous drug use, or alcohol abuse)
- •No known close contact to a confirmed Mtb case (family or social setting)
- •No history of living or travelling in India, China, Sub-Saharan Africa, or Southeast Asia in the past 6 months
- •No exposure (other than casual) to high-risk environments for Mtb exposure (eg, prisons, homeless shelters); healthcare workers are allowed
排除标准
- •Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- •History of anaphylactic type reaction or other severe reaction to PPD in the past, including a history of blistering or sloughing
- •Presence of conditions that may suppress TST reactivity, including:
- •Protocol No. JHP-Aplisol-03 Confidential 04 May 2012 Page 8 of 38
- •Acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (HIV1, HIV2). Mild viral syndromes are allowed.
- •Acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis
- •Acute systemic fungal infection
- •Live virus vaccinations within the past 6 weeks, including measles, mumps, polio, varicella, or FluMist®
- •Metabolic derangements (eg, poorly controlled diabetes, Cushing syndrome, chronic renal failure [as evidenced by a creatinine clearance < 30 ml/min])
结局指标
主要结局
Determination of similarity in responses
时间窗: 72 hours
To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.Skin test responses will be used to determine product similarity in responses.
次要结局
- Determine equivalent specificity(72 hours)
研究者
研究点 (2)
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