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首页> 外文期刊>PLOS Neglected Tropical Diseases >The Challenge of Producing Skin Test Antigens with Minimal Resources Suitable for Human Application against a Neglected Tropical Disease; Leprosy
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The Challenge of Producing Skin Test Antigens with Minimal Resources Suitable for Human Application against a Neglected Tropical Disease; Leprosy

机译：用最少的资源生产适合人类使用的皮肤测试抗原以应对被忽视的热带病的挑战;麻风

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True incidence of leprosy and its impact on transmission will not be understood until a tool is available to measure pre-symptomatic infection. Diagnosis of leprosy disease is currently based on clinical symptoms, which on average take 3–10 years to manifest. The fact that incidence, as defined by new case detection, equates with prevalence, i.e., registered cases, suggests that the cycle of transmission has not been fully intercepted by implementation of multiple drug therapy. This is supported by a high incidence of childhood leprosy. Epidemiological screening for pre-symptomatic leprosy in large endemic populations is required to facilitate targeted chemoprophylactic interventions. Such a test must be sensitive, specific, simple to administer, cost-effective, and easy to interpret. The intradermal skin test method that measures cell-mediated immunity was explored as the best option. Prior knowledge on skin testing of healthy subjects and leprosy patients with whole or partially fractionated Mycobacterium leprae bacilli, such as Lepromin or the Rees' or Convit' antigens, has established an acceptable safety and potency profile of these antigens. These data, along with immunoreactivity data, laid the foundation for two new leprosy skin test antigens, MLSA-LAM (M. leprae soluble antigen devoid of mycobacterial lipoglycans, primarily lipoarabinomannan) and MLCwA (M. leprae cell wall antigens). In the absence of commercial interest, the challenge was to develop these antigens under current good manufacturing practices in an acceptable local pilot facility and submit an Investigational New Drug to the Food and Drug Administration to allow a first-in-human phase I clinical trial.
机译：直到有一种可用来测量症状前感染的工具，才能了解麻风的真正发病率及其对传播的影响。目前，麻风病的诊断基于临床症状，平均需要3-10年才能显现出来。如通过新病例检测所定义的发病率与患病率（即已登记的病例）相等的事实表明，通过实施多种药物疗法尚未完全阻断传播的周期。儿童麻风病发病率高支持了这一点。为了促进靶向化学预防干预，需要对大流行人群的症状前麻风病进行流行病学筛查。这样的测试必须敏感，具体，易于管理，具有成本效益并且易于解释。探索测量细胞介导的免疫力的皮内皮肤测试方法是最佳选择。对健康受试者和麻风病患者的完整或部分分枝的麻风分枝杆菌（如Lepromin或Rees'或Convit'抗原）进行皮肤测试的先验知识已经建立了这些抗原的可接受的安全性和效力。这些数据以及免疫反应性数据为两种新的麻风病皮肤测试抗原奠定了基础，MLSA-LAM（无分支杆菌脂聚糖的M. leprae可溶性抗原，主要是lipoarabinomannan）和MLCwA（M。leprae细胞壁抗原）。在没有商业利益的情况下，面临的挑战是要按照目前的良好生产规范在可接受的当地试验设施中开发这些抗原，然后向食品和药物管理局提交研究新药，以进行人类第一阶段的临床试验。

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