Potent Vaccine Adjuvant Therapeutic

强效疫苗辅助治疗

• 批准号: 7611880
• 负责人: Susan Dana Jones
• 金额: $ 30万
• 依托单位: IMMURX LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7611880
• 关键词: Aerosols; Agonist; Animal Model; Antibody Formation; Antigens; Area; Bacterial Infections; Biological Models; Blood Circulation; CD8B1 gene; Cellular Immunity; Chronic; Clinic; Clinical; Clinical Trials; Combined Vaccines; Communicable Diseases; Complication; DNA; Data; Drug Formulations; Future; Generations; Goals; Immune; Immunity; Immunization; Infection; Injection of therapeutic agent; Lead; Legal patent; Life; Maintenance; Mediating; Memory; Methods; Molecular; Patients; Prevalence; Production; Proteins; T-Lymphocyte; TNFRSF5 gene; Therapeutic; Time; Toll-like receptors; Tuberculosis Vaccines; Vaccination; Vaccine Adjuvant; Vaccines; Viral; base; commercialization; cost; expression vector; innovation; novel; prophylactic; public health relevance; research study; response; tuberculosis immunity

DESCRIPTION (provided by applicant): Protective immunity against chronic infectious diseases such as TB will almost certainly require the generation of potent cellular immunity. To that end, we have recently developed a proprietary form of immunization (combined TLR/CD40-agonist immunization) which elicits a T cell response exponentially greater than traditional vaccination methods, and produces potent protective T cell immune memory. The overall goal of these experiments is to develop a novel and potent vaccine platform for chronic infectious diseases, with a production cost and shelf life consistent with the needs of the third world. We therefore propose to produce and evaluate the generation and maintenance of protective cellular immunity following immunization with both protein-based and DNA-based combined TLR/CD40-agonist vaccine. Importantly we will evaluate these vaccines for their induction of protective immunity against aerosol challenge with TB. While CD40 agonists and TLR agonists have been used separately in previous clinical settings, combining these agonists into a proprietary vaccine formulation is a novel, patented concept with no previous clinical exposure. Thus, the studies proposed below constitute an innovative vaccine platform with the potential for high impact as a prophylactic and/or therapeutic TB vaccine. PUBLIC HEALTH RELEVANCE: Project Narrative ImmuRx has developed a novel, patented vaccine platform capable of generating immunity 10 times greater than conventional vaccination methods. Preliminary data has shown this vaccine to be successful in protecting against both viral and bacterial infections and we will now examine how well the vaccine can protect against infection with TB, a representative of a globally significant chronic infectious disease. The results of these studies will lead to pre-IND studies in anticipation of clinical trials and subsequent commercialization to bring this powerful treatment to patients in need.

描述（由申请人提供）：针对结核病等慢性传染病的保护性免疫几乎肯定需要产生有效的细胞免疫。为此，我们最近开发了一种专有的免疫形式（TLR/CD40 激动剂联合免疫），其引发的 T 细胞反应比传统疫苗接种方法呈指数级增强，并产生有效的保护性 T 细胞免疫记忆。这些实验的总体目标是开发一种新型、有效的慢性传染病疫苗平台，其生产成本和保质期符合第三世界的需求。因此，我们建议在使用基于蛋白质和基于 DNA 的联合 TLR/CD40 激动剂疫苗免疫后，生产并评估保护性细胞免疫的产生和维持。重要的是，我们将评估这些疫苗对结核病气溶胶攻击的保护性免疫诱导作用。虽然 CD40 激动剂和 TLR 激动剂在之前的临床环境中已单独使用，但将这些激动剂组合到专有疫苗配方中是一个新颖的专利概念，之前没有临床接触过。因此，下面提出的研究构成了一个创新的疫苗平台，具有作为预防性和/或治疗性结核疫苗产生巨大影响的潜力。公共健康相关性：Project Narrative ImmuRx 开发了一种新型专利疫苗平台，能够产生比传统疫苗接种方法高 10 倍的免疫力。初步数据表明，这种疫苗能够成功地预防病毒和细菌感染，我们现在将研究该疫苗能够在多大程度上预防结核病感染，结核病是一种全球性慢性传染病的代表。这些研究的结果将导致 IND 前研究，以期进行临床试验和随后的商业化，从而为有需要的患者带来这种强大的治疗方法。