A MULTICENTER, OPEN-LABEL, RANDOMIZED TO ROUTE OF ADMINISTRATION

多中心、开放标签、随机给药途径

• 批准号: 7952170
• 负责人: Christine B. Turley
• 金额: $ 9.22万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952170
• 关键词: Accounting; Acute; Adult; Age-Years; Blood Vessels; Clinical Research; Communicable Diseases; Computer Retrieval of Information on Scientific Projects Database; Dose; Erythema; Escherichia coli; Exhibits; Fatigue; Funding; Genetic Structures; Grant; Health; Human; Induration; Influenza; Institution; International; Lead; Lung diseases; Muscle; Mutation; Pain; Population; Production; Randomized; Reaction; Recombinant Proteins; Research; Research Personnel; Resources; Route; Safety; Seasons; Source; Subcutaneous Tissue; Symptoms; Telephone; Treatment Protocols; United States National Institutes of Health; Vaccines; base; cytokine; diaries; immunogenic; influenza virus vaccine; influenzavirus; novel; novel strategies; open label; uptake

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. Some of the challenges in developing an effective vaccine for influenza occur because influenza viruses exhibit change in genetic structure each season. None of the current vaccines offer protection in a way that accounts for this genetic change. VaxInnate has developed a cross-protective influenza A vaccine, VAX102, which is based on a recombinant protein expressed in E. coli. We have found that 0.3 g and 1.0 g are safe and immunogenic doses when given intramuscularly (IM) and we have found that higher doses such as 10 g are associated with unacceptable symptoms of cytokine release. The subcutaneous tissues are less vascular than muscle and may lead to slower systemic uptake of vaccine. We will assess the safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM, SC, and ID at dose levels 0.3 ¿g, 1 ¿g, and 2¿g in a prime-boost dosing regimen, in healthy adults 18- 49 years of age. Subjects will be asked to keep a diary of local reactions (i.e., erythema, induration) and systemic symptoms such as pain and fatigue. Subjects will be followed frequently during the one month post each dose of study agent, and will be contacted by phone at 6 months following the first vaccine dose. Novel influenza vaccines and new approaches to production are critical to both national and international health.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 流感是一种高度传染性的急性呼吸道疾病，是对人类造成的主要传染病威胁之一，开发有效的流感疫苗面临一些挑战，因为流感病毒在每个季节都表现出基因结构的变化。 VaxInnate 开发了一种交叉保护性甲型流感疫苗 VAX102，它基于大肠杆菌中表达的重组蛋白。肌肉注射 (IM) 时，1.0 g 是安全且具有免疫原性的剂量，我们发现较高剂量（例如 10 g）与细胞因子释放的不可接受的症状相关，皮下组织的血管少于肌肉，可能导致疫苗的全身吸收减慢。我们将评估以 0.3 剂量水平 IM、SC 和 ID 递送的 VAX102 疫苗的安全性、反应原性和耐受性。克, 1 ¿ g 和 2¿ g 在初次-加强剂量方案中，18-49岁的健康成人将要求受试者记录局部反应（即红斑、硬结）和全身症状（例如疼痛和疲劳）。新型流感疫苗和新的生产方法对于国家和国际健康都至关重要。