Vaccine Adjuvant for Rapid Tolerance Induction in Allergy Patients

用于过敏患者快速耐受诱导的疫苗佐剂

基本信息

批准号：
8715688
负责人：
Christopher H Clegg
金额：
$ 28.06万
依托单位：
TRIA BIOSCIENCE CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-07 至 2016-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8715688
关键词：
Adjuvant Admixture Adverse reactions Affect Agonist Allergens Allergic Anaphylaxis Animal Model Businesses Chemicals Child Clinical Clinical Research Cyclic GMP Data Development Development Plans Disease Drug Formulations Effectiveness Evaluation FDA approved Felis catus Food Funding Goals Grant Health Care Costs Human Hypersensitivity IgE Immune Tolerance Immune response Immunity Immunotherapy Incidence Injection of therapeutic agent Insecta Intention Lead Link Lipid A Marketing Mediating Medical Methods Modeling Monitor Oryctolagus cuniculus Outcome Patients Peanuts - dietary Peripheral Blood Mononuclear Cell Pharmaceutical Preparations Pharmacology Phase Phleum Physicians Pollen Population Prevalence Regulation Relative (related person)Resources Rhinitis Risk Route Safety Sales Seasons Series Small Business Innovation Research Grant Symptoms T-Lymphocyte TLR4 gene Time Toxicology Vaccine Adjuvant Vaccines Work World Health Organization airway hyperresponsiveness base crosslink desensitization design disability experience global health immunogenicity innovation interest pre-clinical prevent programs public health relevance subcutaneous sublingual immunotherapy success vaccine candidate vaccine efficacy vaccine safety

项目摘要

DESCRIPTION (provided by applicant): Allergy is a major cause of illness and disability with an estimated 40-50 million people afflicted in the US alone. AIT provides long-term benefits for the patient and its need for optimization creates a compelling business opportunity. There is a very strong rationale to develop GLA for allergy based on its superior drug profile to MPL, a related TLR4 agonist that accelerates desensitization in people. Our preclinical development plan is easy to execute given the vaccines simple design, and it is very low risk given GLA's safety record in toxicology studies and current clinical programs. This Phase I SBIR will clarify the pharmacology and product profile for the IND. The goal is to confirm that GLA will augment the immunogenicity of multiple allergens and verify that it can accelerate desensitization in a compelling manner. The intention is to generate three potential vaccine candidates for evaluation by an external advisory board. In addition to new innovative allergy products, this work will help us understand the mechanisms of IgE-mediated disease and how to effectively "cure" allergy through tolerance induction. TRIA has the resources and experience to complete the task.

描述（由申请人提供）：过敏是导致疾病和残疾的主要原因，仅在美国估计就有 40-5000 万人受到影响。 AIT 为患者提供长期利益，其优化需求创造了令人信服的商机。开发 GLA 治疗过敏是有充分理由的，因为它的药物特性优于 MPL，MPL 是一种相关的 TLR4 激动剂，可加速人体脱敏。鉴于疫苗设计简单，我们的临床前开发计划很容易执行，而且考虑到 GLA 在毒理学研究和当前临床项目中的安全记录，风险非常低。该 I 期 SBIR 将阐明 IND 的药理学和产品概况。目标是确认 GLA 能够增强多种过敏原的免疫原性，并验证它能够以令人信服的方式加速脱敏。目的是产生三种潜在的候选疫苗，供外部顾问委员会评估。除了新的创新过敏产品外，这项工作还将帮助我们了解IgE介导的疾病机制以及如何通过耐受诱导有效“治愈”过敏。 TRIA 拥有完成任务的资源和经验。