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: 10250294
• 负责人: Ali I. Fattom
• 金额: $ 291.65万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10250294
• 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.

食物过敏是一个新出现的健康问题，发病率和严重程度都在增加，特别是在儿童中，并持续到整个成年期。自1990年以来，自我报告的花生过敏发生率显著上升，这对医疗保健系统构成了日益沉重的经济负担。由于没有批准的治疗方法，各种形式的免疫疗法已被评估，但通常不能促进长期保护，并可能产生不良副作用。BlueWillow将利用其水包油纳米乳粘膜佐剂（NE01）制备花生过敏疫苗。在这个SBIR项目中，第一阶段将包括花生过敏小鼠模型的配方活性和疗效评估。在第二阶段，该项目将评估临床前动物模型的长期保护作用，并开展促进ind的活动。