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。杆菌本研究的主要目的是评估VAX 102疫苗以10 μ g、33 μ g和100 μ g 3种剂量肌肉注射的安全性、反应原性和耐受性。 疫苗将在第0天接种，并在第28天对18-49岁的健康成人进行加强接种。 本研究的其他目的是评估对VAX 102疫苗的免疫应答。 将进行实验室研究以评价安全性和免疫应答。要求受试者记录局部反应（即，发红或肿胀）和全身症状如疼痛和疲劳。 将在每次研究药物给药后1个月内频繁随访受试者，并在首次疫苗给药后6个月内以其他间隔随访受试者。开发一种在多个流感季节都具有保护作用的替代流感疫苗，并以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.