A SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, ESCALATING DOSE-RANGING STUDY TO

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 流感是一种高度传染性的急性呼吸道疾病，是威胁人类人口的主要传染病之一。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表现出基因结构的变化。目前的疫苗都没有一种能够解释这种基因变化的保护方式。VaxInnate已经开发出一种交叉保护性甲型流感疫苗，VAX102，它是基于在大肠杆菌中表达的重组蛋白。本研究的主要目的是评估VAX102疫苗的安全性、反应性和耐受性。VAX102疫苗分3次肌肉注射，10g、33g和100g。该疫苗将在第0天接种，第28天接种给18-49岁的健康成年人。这项研究的其他目的是评估VAX102疫苗的免疫反应。将进行实验室研究，以评估安全性和免疫反应。受试者将被要求记录局部反应(即发红或肿胀)以及疼痛和疲劳等全身症状。受试者将在每次注射研究试剂后的一个月内以及在第一次接种疫苗后的6个月内进行频繁的跟踪调查。开发一种替代流感疫苗，这种疫苗将在多个流感季节具有保护作用，并将以一种允许快速生产的方法生产，这对全球健康至关重要。

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. The main purpose of the study is to assess the safety, reactogenicity and tolerability of the VAX102 vaccine given as an injection into the muscle at 3 doses, 10 ¿g, 33 ¿g and 100 ¿g. The vaccine will be given at Day 0 and a booster at Day 28 to healthy adults, 18-49 years of age. Additional purposes of the study are to assess the immune response to the VAX102 vaccine. Laboratory studies will be performed to evaluate safety and immune response. Subjects will be asked to keep a diary of local reactions (i.e., redness or swelling) and systemic symptoms such as pain and fatigue. Subjects will be followed frequently during the one month post each dose of study agent, and at other intervals during the 6 months following the first vaccine dose. Development of an alternative influenza vaccine that will be protective across multiple influenza seasons and will be produced in a method that will allow for rapid production is critical to global health.