Adjuvant Development Program

佐剂开发计划

• 批准号: 8335338
• 负责人: RHEA COLER
• 金额: $ 601.04万
• 依托单位: ACCESS TO ADVANCED HEALTH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8335338
• 关键词: Adjuvant; Agonist; Aluminum Hydroxide; Animal Model; Anti-Bacterial Agents; Antigens; Categories; Cavia; Cessation of life; Clinical; Communicable Diseases; Contracts; Cyclic GMP; DNA Sequence; Development; Development Plans; Drug Formulations; Drug resistance; Drug resistance in tuberculosis; Evolution; Human; Immune response; Immune system; Incidence; Infection; Infectious Diseases Research; Licensing; Lipids; Liposomes; Modeling; Multi-Drug Resistance; Mus; Mycobacterium tuberculosis; National Institute of Allergy and Infectious Disease; Oils; Performance; Process; Program Development; Research Institute; TLR4 gene; TLR7 gene; Tuberculosis Vaccines; United States; Vaccine Adjuvant; Vaccines; Virulent; World Health Organization; aluminum phosphate; cost; in vivo; microorganism; mortality; novel; pathogen; pre-clinical; product development; resistant strain; response; toll-like receptor 4; vaccine candidate; vaccine efficacy

The NIAID/DAIT Adjuvant Development Program supports the development of new candidate vaccine adjuvants that stimulate innate immune responses to protect against infection by NIAID Category A, B, and C Pathogens. Currently, aluminum hydroxide/aluminum phosphate (alum) is the only licensed adjuvant for general human use in the United States. Because alum is not a universally effective adjuvant, additional adjuvants are sought that can stimulate more broadly effective and safe responses to a wide variety of microorganisms. Candidate vaccine adjuvants eligible for support must: 1) be previously identified and characterized as safe, 2) function by activating the innate immune system, 3) have a documented mechanism of action for the adjuvant, 4) be part of a Product Development Plan that will significantly advance the product within the 5 year period of contract performance, and 5) when possible, be able to augment vaccine efficacy safely against an NIAID Category A, B, and C Pathogen upon pathogenic challenge in an in vivo animal model.

NIAID/DAIT佐剂开发项目支持开发新的候选疫苗佐剂，刺激先天免疫反应，以防止NIAID A、B和C类病原体的感染。目前，氢氧化铝/磷酸铝（明矾）是美国唯一获准用于一般人类使用的佐剂。由于明矾不是一种普遍有效的佐剂，因此需要寻找其他佐剂，以刺激对各种微生物更广泛有效和安全的反应。符合支持条件的候选疫苗佐剂必须：1)先前被确定为安全的，2)通过激活先天免疫系统起作用，3)具有记录的佐剂作用机制，4)成为产品开发计划的一部分，将在5年的合同履行期内显著推进产品，5)在可能的情况下，能够在体内动物模型的致病性攻击中安全地增强疫苗对NIAID a， B和C类病原体的效力。