DEVELOPMENT OF NANOVAX TM (OIL IN WATER NANOEMULSION ADJUVANT) FORMULATED ALLERGENS AS INTRANASAL IMMUNOTHERAPEUTIC VACCINES FOR PEANUT ALLERGY.

开发NANOVAX TM（水包油纳米乳剂佐剂）配方过敏原作为花生过敏的鼻内免疫治疗疫苗。

• 批准号: 10018153
• 负责人: Ali I. Fattom
• 金额: $ 29.99万
• 依托单位: BLUEWILLOW BIOLOGICS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018153
• 关键词: Adjuvant; Adult; Allergens; Allergy to peanuts; Animal Model; Antigens; Child; Clinical Trials; Financial Hardship; Food Hypersensitivity; Formulation; Health; Healthcare Systems; Immune response; Immunity; Immunotherapeutic agent; Immunotherapy; Incidence; Mucous Membrane; Oils; Patient Self-Report; Phase; Safety; Severities; Small Business Innovation Research Grant; Testing; Therapeutic; Toxic effect; Vaccines; Water; clinical lot; efficacy evaluation; meetings; mouse model; nanoemulsion; novel; pre-clinical; process optimization; scale up; side effect; vaccine development

Food allergy is an emerging health problem with increasing incidence and severity, particularly in children, and continuing throughout adulthood. Since 1990, the incidence of self-reported peanut allergy has risen significantly representing a mounting financial burden to the healthcare system. With no approved therapeutics available, various forms of immunotherapy have been evaluated but generally do not facilitate long-term protection and can have adverse side effects. BlueWillow will apply its oil-in-water NanoVax nanoemulsion mucosal adjuvant (NE01) to formulate a vaccine against peanut allergy. In this SBIR project, Phase I will consist of formulation activities and the evaluation of efficacy in a mouse model of peanut allergy. In phase II, the project will assess the long-term protection in preclinical animal models and engage in IND-enabling activities.

食物过敏是一种新兴的健康问题，发病率和严重程度不断增加，特别是在儿童中，并持续整个成年期。自1990年以来，自我报告的花生过敏的发病率显着上升，这对医疗保健系统造成了越来越大的经济负担。由于没有批准的治疗方法，已经评估了各种形式的免疫疗法，但通常不利于长期保护，并且可能具有不良副作用。BlueWillow将应用其水包油NanoVax纳米乳液粘膜佐剂（NE01）来配制抗花生过敏的疫苗。在该SBIR项目中，第一阶段将包括配方活动和在花生过敏小鼠模型中的疗效评价。在第二阶段，该项目将评估临床前动物模型的长期保护，并参与IND使能活动。