A Second-Generation Patch Test for Tuberculosis

第二代结核病斑贴试验

• 批准号: 6702042
• 负责人: Carol A. Nacy
• 金额: $ 23.77万
• 依托单位: SEQUELLA, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-15 至 2007-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6702042
• 关键词: Mycobacterium tuberculosis; Peru; bacterial antigens; bacterial proteins; biopsy; bioterrorism /chemical warfare; clinical research; clinical trial phase I; clinical trial phase II; communicable disease diagnosis; cooperative study; diagnosis design /evaluation; diagnosis quality /standard; diagnostic tests; human subject; noninvasive diagnosis; patient oriented research; protein purification; rapid diagnosis; recombinant proteins; transdermal drug delivery; transfection /expression vector; tuberculosis

DESCRIPTION (provided by applicant): This proposal outlines a development program to transition a second generation Transdermal Tuberculosis (TB) Skin Test into a commercial product. The first generation of the technology, transdermal delivery of a protein of the M. tuberculosis complex (MPB/T-64) by a Torii patch, has already been tested in three clinical trials performed in the Philippines and Japan: it demonstrated remarkable ability to specifically identify active cases of TB (smear positive TB patients), while it was non-reactive in symptom-free individuals PPD positive from either BCG vaccination or prior cure of TB. Sequella licensed this exciting technology from the Japan BCG Laboratory, and GMP manufacturing of recombinant MPT64 began in January 2003. We will begin a World Health Organization-supported clinical trial in South Africa in March 2003 that will test the sensitivity and specificity of this first generation test. We believe that the Transdermal TB Skin Test will be an invaluable tool in the fight against TB. Because of the incredible need for a rapid diagnostic for active TB, we hope to begin distribution in the developing world as soon as possible using the existing test format. However, there are many aspects of the product that need to be improved, and we hope to develop a more effective second generation product in this proposal. Our specific aims include: Specific Aim I: We will optimize expression, purification, and quality control protocols for MPT64. Specific Aim II: We will complete development of a second-generation patch technology that incorporates the protein directly into the patch adhesive. Specific Aim III: We will manufacture the second-generation patches for clinical studies using Good Manufacturing Practices. Specific Aim IV: We will perform clinical studies of the Transdermal TB Skin Test.

描述（由申请人提供）： 该提案概述了一项开发计划，该计划将第二代经皮结核（TB）皮肤测试转变为商业产品。第一代技术，即结核分枝杆菌复合物的蛋白质（MPB/T-64）通过Torii贴片的透经递送，已经在菲律宾和日本进行的三项临床试验中进行了测试：它表现出显着的TB（Smear Pastion TB患者）的显着能力（否则TB患者），同时它是by-Recure或BC pp pp pp cyom cyom cyom cyom cyom cyom cyom cyom cyom cyom cyom cyom cyom in suncy的临床试验。 TB。 Sequella从日本BCG实验室获得了这项激动人心的技术，重组MPT64的GMP制造于2003年1月开始。我们将于2003年3月在南非开始进行世界卫生组织支持的临床试验，该试验将测试该第一代测试的敏感性和特异性。 我们认为，透皮结核病皮肤测试将是与结核病斗争的宝贵工具。由于需要快速诊断活跃结核病，我们希望使用现有的测试格式尽快开始在发展中国家的分发。但是，产品的许多方面需要改进，我们希望在该建议中开发更有效的第二代产品。我们的具体目的包括： 特定目的I：我们将优化MPT64的表达，纯化和质量控制方案。 特定目标II：我们将完成将蛋白质直接纳入贴片粘合剂的第二代贴片技术的开发。 特定的目标III：我们将使用良好的制造实践制造用于临床研究的第二代斑块。 特定的目标IV：我们将对透皮结核皮肤测试进行临床研究。