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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 流感是一种高度传染性的急性呼吸道疾病，是威胁人类的主要传染病之一。 开发有效的流感疫苗的一些挑战是因为流感病毒在每个季节都会表现出遗传结构的变化。 目前没有一种疫苗能以这种基因变化的方式提供保护。 VaxInnate开发了一种交叉保护性甲型流感疫苗VAX 102，该疫苗基于在大肠杆菌中表达的重组蛋白。杆菌我们已经发现，当肌内（IM）给予时，0.3g和1.0g是安全的和免疫原性的剂量，并且我们已经发现更高的剂量如10 g与细胞因子释放的不可接受的症状相关。皮下组织的血管比肌肉少，可能导致疫苗的全身吸收较慢。 我们将在18- 49岁的健康成人中评估以初免-加强给药方案以0.3 μ g、1 μ g和2 μ g剂量水平IM、SC和ID递送的VAX 102疫苗的安全性、反应原性和耐受性。 要求受试者记录局部反应（即，红斑、硬结）和全身症状如疼痛和疲劳。 每次接种研究药物后一个月内，将对受试者进行频繁随访，并在首次接种疫苗后6个月通过电话联系受试者。新型流感疫苗和新的生产方法对国家和国际卫生至关重要。