Safety, Sensitivity and Specificity of Spherule-derived Coccidioidin in Naive Adults, in Adults With a History of Pulmonary Coccidioidomycosis and in Adults With a History of Pulmonary Histoplasmosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis.
研究概览
简要总结
Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good Health (absence of active medical disease)
- •Meets criteria specific to population groups:
- •Coccidioidomycosis Group:
- •History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings
- •Histoplasmosis Group:
- •History of pulmonary histoplasmosis
- •Naive Control Group:
- •Lifetime residence in the states of WA, OR, ID, or MT
- •Never employed as an agricultural worker
- •Serology negative for C.immitis antibodies
排除标准
- •(All Groups):
- •Active medical disease
- •Alcohol abuse or illicit drug use
- •Influenza-like illness within the past 4 weeks
- •Immunizations within the past 4 weeks
- •Current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria
- •Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs
- •Immunodeficiency disease
- •HIV infection
- •Previous skin test with coccidioidin or SD Coccidioidin
- •Pregnant or lactating
- •Adverse reaction to thimerosal
- •Adverse reaction to Candida or Trichophyton skin test antigens
- •Coccidioidomycosis Group:
- •Current cavitary or disseminated coccidioidomycosis
- •History of histoplasmosis, or blastomycosis
- •Histoplasmosis Group:
- •History of coccidioidomycosis or blastomycosis
- •Naive Control Group:
- •History of coccidioidomycosis, histoplasmosis, blastomycosis
- •Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 days in restricted areas of CA, AZ and TX.
研究组 & 干预措施
1
Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.
干预措施: Spherule-derived coccidioidin (Biological)
2
Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).
干预措施: Spherule-derived coccidioidin (Biological)
3
Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.
干预措施: Spherule-derived coccidioidin (Biological)
结局指标
主要结局
To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis.
时间窗: 48 hours
次要结局
- Determine the specificity of spherule-derived coccidioidin by testing the skin test antigen in naive adult volunteer and volunteers with a history of pulmonary histoplasmosis.(48 hours)